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Swedish Bladder Cancer Registry - Cystectomy - Follow-Up

- 2021-09-27 - 1 Formulär, 5 Item-grupper, 106 Dataelement, 2 Språk
Item-grupper: General Information, Preoperative Data, Perioperative Data, Postoperative Data, Complications and Reoperations
Swedish Bladder Cancer Registry Healthcare Quality http://www.cancercentrum.se/vast/cancerdiagnoser/urinvagar/urinblase--och-urinvagscancer/kvalitetsregister/dokument/ Cystectomy - Follow-Up

ICHOM Overactive bladder - Female Baseline Measures

- 2020-04-30 - 1 Formulär, 7 Item-grupper, 31 Dataelement, 1 Språk
Item-grupper: Administrative Data, Demographics, Baseline clinical factors, Explanatory variable, OAB symptom severity and burden, Health Related Quality of Life, Sexual function
ICHOM Overactive bladder data collection Version 1.2.2 Revised: April 10th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For Overactive Bladder, the following treatment approaches (or interventions) are covered by our Standard Set. Treatment Approaches : Patient education | Behavioral modification | Pharmacological management | Intradetrusor Botox, PTNS, SNS | Surgery This document contains the Female Baseline Measures form. It has to be filled in at Baseline. This document also should also be filled out repeatedly in the event of symptom recurrence. Collecting Clinician and Patient-Reported Outcome Measures: ICIQ-OAB, ICIQ-MLUTSsex and ICIQ-FLUTSsex. For all: Free for use in clinical practice, routine outcomes measurement, and clinical research. As permission from the developer is required, only the total score will be included in this version of the standard set. To obtain permission and an offical copy and scoring guide or to inquire about translations see http://www.iciq.net/userpolicy.html OAB-q SF (4-week recall). As a license is needed for use of this questionnaire, only the total score will be included in this version of the standard set. TBS. Free for use without a license. Please see Colman S et al (2008) Validation of the treatment benefit scale for assessing subjective outcomes in Treatment of Overactive Bladder. Urology 72:803-807 ICHOM's Standard set was supported by IUGA (international urogynecological association), National Association for Continence, The Canadian Continence Foundation, Continence Foundation of Australia Publication: Foust-Wright C, Wissig S, Stowell C, et al. Development of a core set of outcome measures for OAB treatment. Int Urogynecol J. 2017;28(12):1785–1793. doi:10.1007/s00192-017-3481-6 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Overactive bladder - Male Baseline Measures

- 2020-04-30 - 1 Formulär, 7 Item-grupper, 30 Dataelement, 1 Språk
Item-grupper: Administrative Data, Demographics, Baseline clinical factors, Explanatory variable, OAB symptom severity and burden, Health Related Quality of Life, Sexual function
ICHOM Overactive bladder data collection Version 1.2.2 Revised: April 10th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For Overactive Bladder, the following treatment approaches (or interventions) are covered by our Standard Set. Treatment Approaches : Patient education | Behavioral modification | Pharmacological management | Intradetrusor Botox, PTNS, SNS | Surgery This document contains the Male Baseline Measures form. It has to be filled in at Baseline. This document also should also be filled out repeatedly in the event of symptom recurrence. Collecting Clinician and Patient-Reported Outcome Measures: ICIQ-OAB, ICIQ-MLUTSsex and ICIQ-FLUTSsex. For all: Free for use in clinical practice, routine outcomes measurement, and clinical research. As permission from the developer is required, only the total score will be included in this version of the standard set. To obtain permission and an offical copy and scoring guide or to inquire about translations see http://www.iciq.net/userpolicy.html OAB-q SF (4-week recall). As a license is needed for use of this questionnaire, only the total score will be included in this version of the standard set. TBS. Free for use without a license. Please see Colman S et al (2008) Validation of the treatment benefit scale for assessing subjective outcomes in Treatment of Overactive Bladder. Urology 72:803-807 ICHOM's Standard set was supported by IUGA (international urogynecological association), National Association for Continence, The Canadian Continence Foundation, Continence Foundation of Australia Publication: Foust-Wright C, Wissig S, Stowell C, et al. Development of a core set of outcome measures for OAB treatment. Int Urogynecol J. 2017;28(12):1785–1793. doi:10.1007/s00192-017-3481-6 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Overactive bladder - Female Follow-up

- 2020-04-30 - 1 Formulär, 7 Item-grupper, 17 Dataelement, 1 Språk
Item-grupper: Administrative Data, Explanatory variable, OAB symptom severity and burden, Health Related Quality of Life, Sexual function, Side effects and burden of treatment, Treatment satisfaction
ICHOM Overactive bladder data collection Version 1.2.2 Revised: April 10th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For Overactive Bladder, the following treatment approaches (or interventions) are covered by our Standard Set. Treatment Approaches : Patient education | Behavioral modification | Pharmacological management | Intradetrusor Botox, PTNS, SNS | Surgery This document contains the Female Follow-up form. Follow-up continues every three months until either the treatment is successful and the patient is discharged from care or the patient is lost to follow-up. Collecting Clinician and Patient-Reported Outcome Measures: ICIQ-OAB, ICIQ-MLUTSsex and ICIQ-FLUTSsex. For all: Free for use in clinical practice, routine outcomes measurement, and clinical research. As permission from the developer is required, only the total score will be included in this version of the standard set. To obtain permission and an offical copy and scoring guide or to inquire about translations see http://www.iciq.net/userpolicy.html OAB-q SF (4-week recall). As a license is needed for use of this questionnaire, only the total score will be included in this version of the standard set. TBS. Free for use without a license. Please see Colman S et al (2008) Validation of the treatment benefit scale for assessing subjective outcomes in Treatment of Overactive Bladder. Urology 72:803-807 ICHOM's Standard set was supported by IUGA (international urogynecological association), National Association for Continence, The Canadian Continence Foundation, Continence Foundation of Australia Publication: Foust-Wright C, Wissig S, Stowell C, et al. Development of a core set of outcome measures for OAB treatment. Int Urogynecol J. 2017;28(12):1785–1793. doi:10.1007/s00192-017-3481-6 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Overactive bladder - Male Follow-up

- 2020-04-30 - 1 Formulär, 7 Item-grupper, 17 Dataelement, 1 Språk
Item-grupper: Administrative Data, Explanatory variable, OAB symptom severity and burden, Health Related Quality of Life, Sexual function, Side effects and burden of treatment, Treatment satisfaction
ICHOM Overactive bladder data collection Version 1.2.2 Revised: April 10th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For Overactive Bladder, the following treatment approaches (or interventions) are covered by our Standard Set. Treatment Approaches : Patient education | Behavioral modification | Pharmacological management | Intradetrusor Botox, PTNS, SNS | Surgery This document contains the Male Follow-up form. Follow-up continues every three months until either the treatment is successful and the patient is discharged from care or the patient is lost to follow-up. Collecting Clinician and Patient-Reported Outcome Measures: ICIQ-OAB, ICIQ-MLUTSsex and ICIQ-FLUTSsex. For all: Free for use in clinical practice, routine outcomes measurement, and clinical research. As permission from the developer is required, only the total score will be included in this version of the standard set. To obtain permission and an offical copy and scoring guide or to inquire about translations see http://www.iciq.net/userpolicy.html OAB-q SF (4-week recall). As a license is needed for use of this questionnaire, only the total score will be included in this version of the standard set. TBS. Free for use without a license. Please see Colman S et al (2008) Validation of the treatment benefit scale for assessing subjective outcomes in Treatment of Overactive Bladder. Urology 72:803-807 ICHOM's Standard set was supported by IUGA (international urogynecological association), National Association for Continence, The Canadian Continence Foundation, Continence Foundation of Australia Publication: Foust-Wright C, Wissig S, Stowell C, et al. Development of a core set of outcome measures for OAB treatment. Int Urogynecol J. 2017;28(12):1785–1793. doi:10.1007/s00192-017-3481-6 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Swedish Bladder Cancer Registry - 5-Year Follow-Up

- 2017-11-19 - 1 Formulär, 2 Item-grupper, 15 Dataelement, 2 Språk
Item-grupper: General Information, Follow-Up
Swedish Bladder Cancer Registry Healthcare Quality http://www.cancercentrum.se/vast/cancerdiagnoser/urinvagar/urinblase--och-urinvagscancer/kvalitetsregister/dokument/ 5-year Follow-Up

Bladder Cancer NCT01224665 - Pre-Randomization Off-Study Form Bladder Cancer #52060 S1011 NCT01224665

- 2015-03-24 - 1 Formulär, 5 Item-grupper, 24 Dataelement, 1 Språk
Item-grupper: Header Module, Treatment Information, Off Treatment Reason, Additional Treatment, Vital Status
S1011 Pre-Randomization Off-Study Form (#52060) Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer NCT01224665 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9399F2B7-7E68-06C0-E040-BB89AD436952

On-Study - Superficial Bladder Cancer - On-Study Form - 2019333v2.31 - Superficial Bladder Cancer - On-Study Form

- 2015-01-08 - 1 Formulär, 5 Item-grupper, 43 Dataelement, 1 Språk
Item-grupper: CRF Header, BLADDER: FORM ADMINISTRATION, BLADDER: DISEASE DESCRIPTION FOR SUPERFICIAL BLADDER CARCINOMA, SUPERFICIAL BLADDER DISEASE: PRIOR TREATMENT AFFECTING THE BLADDER, Comments
Superficial Bladder Cancer - On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99CD59C5-A961-3FA4-E034-080020C9C0E0

dbGaP phs000346 Cancer Genetic Markers of Susceptibility for Bladder Cancer (CGEMS Bladder) - pht002184.v2.p2

- 2022-10-12 - 5 Formulär, 1 Item-grupp, 3 Dataelement, 1 Språk
Item-grupp: pht002184
Principal Investigator: Nathaniel Rothman, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Department Health and Human Services, Bethesda, MD, USA MeSH: Urinary Bladder Neoplasms,Carcinoma https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000346 This study funded by the National Cancer Institute (NCI) involves conducting a genome-wide association study of common genetic variants to identify markers of susceptibility to bladder cancer. This bladder GWAS has led to the discovery of three novel regions in the genome associated with bladder cancer risk. Cases were defined as individuals having histologically confirmed primary carcinoma of the urinary bladder, including carcinoma in situ (ICD-0-2 topography codes C67.0-C67.9 or ICD9 codes 188.1-188.9). Scan data were obtained from two case-control studies carried out in Spain and the United States (specifically, those in the Maine and Vermont components of the New England Bladder Cancer Study) and three prospective cohort studies in Finland and the United States (specifically Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study, Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial, and The American Cancer Society Cancer Prevention Study II Nutrition Cohort). We used data from 591,637 single nucleotide polymorphisms 3,532 affected individuals (cases) and 5,119 controls of European descent and replication including 8382 cases and 48275 controls from 16 studies. In a combined analysis, we identified three new regions associated with bladder cancer on chromosomes 22q13.1, 19q12 and 2q37.1: rs1014971, (P ≈ 8 x 10sup-12/sup) maps to a non-genic region of chromosome 22q13.1, rs8102137 (P = 2 x 10sup-11/sup) on maps to CCNE1 and rs11892031 (P = 1 x 10sup-7/sup) maps to the UGT1A cluster on 2q37.1. We confirmed four previously identified genome-wide associations on chromosomes 3q28, 4p16.3, 8q24.21 and 8q24.3 (Rothman N et al., Nature Genetics, 2010, PMID: 20972438). Through meta-analysis with the MD Anderson Texas Bladder Cancer Study (TXBCS), we also identified a novel susceptibility locus that mapped to a region of 18q12.3, marked by rs7238033 (P = 8.7 x 10(-9); allelic odds ratio 1.20 with 95% CI: 1.13-1.28) and two highly correlated SNPs, rs10775480/rs10853535 (r(2)= 1.00; P = 8.9 x 10(-9); allelic odds ratio 1.16 with 95% CI: 1.10-1.22) (Garcia-Closas M et al, Human Molecular Genetics, 2011) For NCI-GWAS2, we performed genotyping on cases and controls for the New Hampshire component of the New England Bladder Cancer Study (NEBCS-NH). For the majority of new bladder cancer cases, we genotyped only cases from four case-control studies, the Los Angeles Bladder Cancer Study (LABCS), the French Center for Research on Prostate Diseases (CeRePP), the French Bladder Study (FBCS) and the Brescia Bladder Cancer Study (BBCS). We used existing control data from four cohort studies already genotyped and subjected to rigorous quality control metrics: the European Prospective Investigation Into Cancer and Nutrition Study (EPIC), Womens Health Initiative (WHI), Health Professionals Follow-up Study (HPFS), Nurses Health Study (NHS), which have been a part of Cancer Genetic Markers of Susceptibility (CGEMS). Meta-analysis of NCI-GWAS1, NCI-GWAS2 and a previously reported GWAS TXBCS-GWAS along with taqman replication, identified two new loci: rs10936599 on 3q26.2 (P = 4.53 x 10(-9)) and rs907611 on 11p15.5 (P = 4.11 x 10(-8)). Two notable loci were also identified that approached genome-wide statistical significance: rs6104690 on 20p12.2 (P = 7.13 x 10(-7)) and rs4510656 on 6p22.3 (P = 6.98 X 10(-7)); these require further studies for confirmation (Figueroa J et al, Human Molecular Genetics, 2013).

pht002185.v2.p2

1 Item-grupp 4 Dataelement

pht004007.v1.p2

1 Item-grupp 4 Dataelement

Eligibility

1 Item-grupp 1 Dataelement

pht002183.v2.p2

1 Item-grupp 3 Dataelement

MRT SHIP-Trend-0 MRT-findings: bladder

- 2017-12-08 - 1 Formulär, 1 Item-grupp, 7 Dataelement, 2 Språk
Item-grupp: MRT-findings: bladder
MRT-findings: bladder form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIPTrend0.MRT.MRTBEF.MRTHARN. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html.
 Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

Follow-Up Form Bladder Cancer (NCT00942331)

- 2015-01-08 - 1 Formulär, 8 Item-grupper, 44 Dataelement, 1 Språk
Item-grupper: Header, Vital Status, Treatment Status, Disease Assessment, Measurable Disease Response, Notice of New Primary, Long-Term Toxicity, Non-Protocol Therapy
CALGB 90601: Follow-Up Form Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer NCT00942331 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6591C082-D8C1-EC1C-E040-BB89AD43479B

On-Study - Muscle Invasive Bladder Cancer - On-Study Form - 2019331v2.31 - Muscle Invasive Bladder Cancer - On-Study Form

- 2015-01-08 - 1 Formulär, 5 Item-grupper, 60 Dataelement, 1 Språk
Item-grupper: CRF Header, BLADDER: FORM ADMINISTRATION, BLADDER: DISEASE DESCRIPTION FOR MUSCLE INVASIVE BLADDER CANCER, MUSCLE INVASIVE BLADDER DISEASE: PRIOR TREATMENT AFFECTING THE BLADDER, Comments
Muscle Invasive Bladder Cancer - On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99CD59C5-A95D-3FA4-E034-080020C9C0E0

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