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Eligibility Cancer NCT00756847

- 10/11/17 - 1 modulo, 2 itemgroups, 20 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Safety Study of XL147 (SAR245408), in Combination With Paclitaxel and Carboplatin in Adults With Solid Tumors; ODM derived from: https://clinicaltrials.gov/show/NCT00756847

dbGaP phs001321 Consortium of Investigators of Modifiers of BRCA1/2 (CIMBA) - pht006195.v1.p1

- 09/03/23 - 5 moduli, 1 ItemGroup, 2 elementi, 1 linguaggio
ItemGroup: pht006195
Principal Investigator: Christopher I Amos, PhD, Geisel School of Medicine at Dartmouth, Hanover, NH, USA MeSH: Breast Neoplasms,Ovarian Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001321 The data come from 40 studies participating in the Consortium of Investigators of Modifiers of BRCA1/2 (CIMBA). CIMBA recruits individuals with pathogenic mutations in BRCA1 or BRCA2. The majority of carriers were recruited through cancer genetics clinics offering genetic testing, and were enrolled into national or regional studies. The remainder were identified by population-based sampling of cases, or community recruitment. Eligibility to participate is restricted to carriers of pathogenic BRCA1/2 mutations who were 18 years or older at recruitment. Information collected included amongst other variables: age at recruitment; ages at breast and ovarian cancer diagnosis; and estrogen receptor (ER) status. Samples were genotyped using the Illumina OncoArray beadchip 500K SNP custom array. Details of the genotyping process and sample selection are included in Phelan et al, Identification of twelve new susceptibility loci for different histotypes of epithelial ovarian cancer, Nat Genet. 2017 May;49(5):680-691 (PMID:28346442), and Milne et al, Identification of ten variants associated with risk of estrogen receptor negative breast cancer, Nat Genet (in press).

pht006196.v1.p1

1 ItemGroup 3 elementi

pht006197.v1.p1

1 ItemGroup 9 elementi

pht006198.v1.p1

1 ItemGroup 5 elementi

Eligibility

1 ItemGroup 1 elemento

dbGaP phs001034 New England-Based Case-Control Study of Ovarian Cancer (NECC) - pht005187.v1.p1

- 29/06/23 - 3 moduli, 1 ItemGroup, 5 elementi, 1 linguaggio
ItemGroup: pht005187
Principal Investigator: Daniel W. Cramer, MD, ScD, Brigham and Women's Hospital, Boston, MA, USA MeSH: Ovarian Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001034 The case-control data provided to dbGaP were collected under NCI grant number CA54419 which had 3 enrollment phases: I (1992-1997), II (1998-2002) and III (2003-2008). Altogether, CA54419 funded 15 years of data and specimen collection, resulting in one of the longest running population based case-control studies of ovarian cancer. The study goal was to examine reproductive factors, lifestyle exposures, and genetic background in relation to ovarian cancer risk. The project recruited cases from Eastern Massachusetts and New Hampshire, and became known as the New England-based Case-Control study (NECC) of ovarian cancer. 3957 ovarian cancer cases diagnosed at ages 18-80 and residing in Eastern Massachusetts and New Hampshire were identified through tumor boards and registries. Of these, 3083 (78%) were eligible and among those eligible, 2203 (71%) were enrolled. After excluding 127 non-epithelial and 35 mixed mesodermal tumors, 2041 cases with epithelial tumors of ovarian, primary peritoneal, and fallopian tube origin, including borderline malignancies were included. On average, cases were interviewed 10 months after their diagnosis. A pathologist reviewed pathology reports and recorded histologic subtype, grade, and stage. Mixed ovarian cancers described as predominantly one type were classified as that type. Undifferentiated, transitional cell tumors, or mixed serous/transitional cell tumors were counted as serous. Other mixed epithelial, malignant Brenner, and unspecified epithelial tumors were classified as other. 2100 controls were identified through random digit dialing (RDD), driver-license lists, and town-resident lists. During the first funding phase from 1992 to 1997, 420 (72%) controls identified through RDD and 102 (51%) through town-resident lists agreed to participate. From 1998 to 2008, only town-resident lists were used to identify potential controls. 4366 controls were identified, of whom 1426 (33%) were ineligible if they had died, moved, or were seriously ill or if they did not have a working telephone, speak English, or have at least one ovary. Of eligible controls, 1362 (46%) declined to participate by phone or via 'opt-out' postcard and 1578 (54%) were enrolled. Controls were frequency matched to cases by 5-year age groups and region of residence. In all phases, after written informed consent, demographic information, reproductive and medical history, and habits were assessed by in-person or telephone interview (in a few instances). All of the questions were framed with respect to a reference date defined as 1 year before the diagnosis date for women in the case group and the date of interview for those in the control group. This study was approved by institutional review boards at Dana Farber Harvard Cancer Center and Dartmouth Medical Center.

pht005188.v1.p1

1 ItemGroup 79 elementi

Eligibility

1 ItemGroup 2 elementi

dbGaP phs001133 Follow-up of Ovarian Cancer Genetic Association and Interaction Studies (FOCI) - pht007499.v1.p1

- 16/06/23 - 10 moduli, 1 ItemGroup, 8 elementi, 1 linguaggio
ItemGroup: pht007499
Principal Investigator: Thomas A. Sellers, PhD, MPH, Moffitt Cancer Center, Tampa, FL, USA MeSH: Ovarian Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001133 *(Excerpted/paraphrased from original grant application)*: FOCI seeks to expand our understanding of epithelial ovarian cancer through a coordinated and comprehensive approach. Project 1 will focus on discovery, expansion, and replication. By pooling GWAS, we expect to identify new associations and achieve independent replication, explore whether there are risk variants specific for histologic subtypes, and evaluate structural polymorphisms - copy number variants - as risk factors. Finally, Project 1 will leverage the GWAS data to correlate DNA variants with a new endpoint - survival. Project 2 will focus on biological studies designed to help inform interpretation of findings from Project 1. This will include efforts to identify the functional consequences of variants and improve understanding of biological mechanisms. Project 3 will include epidemiologic studies of gene by gene interaction, gene by environment interaction, and development of risk prediction models. The collective effort builds upon the strengths and history of collaboration inherent in the Ovarian Cancer Association Consortium (OCAC), a multidisciplinary group comprised of epidemiologists, genetic epidemiologists, statistical geneticists, molecular and cell biologists and clinicians that was formed in 2005. *The FOCI Cohort is utilized in the following dbGaP sub-studies.* To view genotypes, other molecular data, and derived variables collected in these sub-studies, please click on the following sub-studies below or in the "Sub-studies" box located on the right hand side of this top-level study page phs001133 FOCI Cohort.- phs001131 Affymetrix Exome Chip - phs001132 GWAS Meta Analysis - phs001142 Mayo Omni Express - phs001150 Mayo 2 5M

pht007495.v1.p1

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pht007496.v1.p1

1 ItemGroup 4 elementi

pht007497.v1.p1

1 ItemGroup 6 elementi

pht007498.v1.p1

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pht007500.v1.p1

1 ItemGroup 5 elementi

pht010306.v1.p1

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dbGaP phs000897 Mayo Clinic and Illumina Collaborative Early Stage Ovarian Cancer (ESOC) Study - pht004637.v1.p1

- 02/04/24 - 5 moduli, 1 ItemGroup, 5 elementi, 1 linguaggio
ItemGroup: pht004637
Principal Investigator: Ellen L. Goode, Mayo Clinic, Rochester, MN, USA MeSH: Cystadenocarcinoma, Serous,Ovarian Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000897 Twenty five patients with early stage carcinoma (Stage I and II) of the ovary were consented for this study. As part of a collaborative agreement with Illumina Inc, Tumor-DNA and patient matched normal DNA from blood underwent whole genome sequencing and microarray genotyping and RNA underwent RNASeq. Tissue also underwent IHC staining for TP53 mutations. The aim of the study was to profile the genomic landscape of these early tumors to discover biomarkers for early detection or subgrouping into different genomic or outcome subgroups. Analyses performed include somatic mutation analysis, RNASeq mutation analysis, LOH analysis, structural variant detection. The current release of this study focusses on 17 patients with serous carcinoma and stage 1 or 2 and with high grade (3 or 4).

pht004638.v1.p1

1 ItemGroup 3 elementi

pht004640.v1.p1

1 ItemGroup 5 elementi

Eligibility

1 ItemGroup 2 elementi

pht004639.v1.p1

1 ItemGroup 50 elementi

Quality Assurance Checklist For Potential Genetic Liability By Breast Cancer and Ovarian Cancer - Checklist

- 26/06/16 - 1 modulo, 4 itemgroups, 79 elementi, 1 linguaggio
Itemgroups: Patient information, Hereditary factor Siblings children, Hereditary factor Maternal Relative, Hereditary factor Paternal Relative
Documentation form for quality assurance in German Health Care by the Aerztekammer Wesfalen-Lippe, http://www.aekwl.de/index.php?id=1788, Form version 30. März 2016 (C)

Ovarian Cancer NCT00954174 On-Study - Gynecologic Oncology Group Recurrent Gynecologic Cancer - On Study Form (Form OSR) - 2728090v1.0 - Gynecologic Oncology Group Recurrent Gynecologic Cancer - On Study Form (Form OSR)

- 09/01/15 - 1 modulo, 5 itemgroups, 32 elementi, 1 linguaggio
Itemgroups: HEADER MODULE, DISEASE DESCRIPTION - PRIOR HISTORY, DISEASE DESCRIPTION - CURRENT HISTORY, PRIOR TREATMENT FOR GYNECOLOGIC CANCER, Comments Module
Gynecologic Oncology Group Recurrent Gynecologic Cancer - On Study Form (Form OSR) Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed Persistent or Recurrent Uterine or Ovarian Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4582476E-F7EA-478B-E044-0003BA3F9857

Ovarian Cancer NCT00954174 Pre-Study - Pre-Treatment Summary Form (DR) - 2847792v1.0 - Pre-Treatment Summary Form (DR)

- 09/01/15 - 1 modulo, 3 itemgroups, 24 elementi, 1 linguaggio
Itemgroups: HEADER MODULE, NON-INVASIVE DIAGNOSTIC PROCEDURES, COMMENTS
Pre-Treatment Summary Form (DR) Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed Persistent or Recurrent Uterine or Ovarian Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=64F29740-03E8-692F-E040-BB89AD432164

Ovarian Cancer NCT00954174 Registration - GOG-0261: Fast Fact Sheet for Protocol 0261 (Uterine Corpus, Ovary) - 2949744v1.0 - GOG-0261: Fast Fact Sheet for Protocol 0261 (Uterine Corpus, Ovary)

- 09/01/15 - 1 modulo, 5 itemgroups, 53 elementi, 1 linguaggio
Itemgroups: Patient Information, Eligibility 1, Eligibility 2, Eligibility 3, Provide comments about this Fast Fact Sheet
GOG-0261: Fast Fact Sheet for Protocol 0261 (Uterine Corpus, Ovary) Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed Persistent or Recurrent Uterine or Ovarian Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=74E5BFDB-0F29-45AE-E040-BB89AD432FB0

On-Study - Primary Ovarian Cancer - On-Study Form - 2019341v2.31 - Primary Ovarian Cancer - On-Study Form

- 08/01/15 - 1 modulo, 6 itemgroups, 39 elementi, 1 linguaggio
Itemgroups: CRF Header, OVARIAN: FORM ADMINISTRATION, OVARIAN: DISEASE DESCRIPTION, OVARIAN: FINDINGS FROM PRIMARY SURGERY, OVARIAN: POST-OPERATIVE FINDINGS FOLLOWING SURGERY, Comments
Primary Ovarian Cancer - On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99CD59C5-A972-3FA4-E034-080020C9C0E0

Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99CD59C5-A982-3FA4-E034-080020C9C0E0 - Ovarian Cancer - Pathology Form

- 08/01/15 - 1 modulo, 3 itemgroups, 67 elementi, 1 linguaggio
Itemgroups: CRF Header, OVARIAN PATHOLOGY: FORM ADMINISTRATION, OVARIAN PATHOLOGY: DISEASE ASSESSMENT
Ovarian Cancer - Pathology Form

Pathology - Ovarian Cancer - Pathology Form - 2019349v2.31 - Ovarian Cancer - Pathology Form

- 08/01/15 - 1 modulo, 3 itemgroups, 67 elementi, 1 linguaggio
Itemgroups: CRF Header, OVARIAN PATHOLOGY: FORM ADMINISTRATION, OVARIAN PATHOLOGY: DISEASE ASSESSMENT
Ovarian Cancer - Pathology Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99CD59C5-A982-3FA4-E034-080020C9C0E0

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