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Cancer Treatments Protocol PhenX Toolkit

- 4/26/16 - 1 form, 1 itemgroup, 18 items, 1 language
Itemgroup: PhenX - cancer treatment protocol
These questions start by asking if the respondent has had cancer. For respondents who have had cancer, detailed follow-up questions ask about the type of cancer treatment, including surgery, chemotherapy, radiation, and hormone therapy. ODM derived from: https://cde.nlm.nih.gov Primary source: https://www.phenxtoolkit.org/ Recent publication: Hendershot, T., Pan, H., Haines, J., Harlan, W.R., Marazita, M.L., McCarty, C.A., Ramos, E.M., and Hamilton, C.M. (2015) Using the PhenX toolkit to add standard measures to a study. Curr. Protoc. Hum. Genet. 86:1.21.1-1.21.17. doi: 10.1002/0471142905.hg0121s86 Permission to publish granted by Carol M. Hamilton.

Cancer: Personal and Family History Protocol PhenX Toolkit

- 9/20/21 - 1 form, 1 itemgroup, 9 items, 1 language
Itemgroup: PhenX - cancer - personal and family history protocol
This protocol is used to assess if the respondent and his or her biological parents, siblings, and children have had cancer. This protocol also obtains information about vital status, age, type of cancer, age at first diagnosis, and any additional cancer diagnoses. ODM derived from: https://cde.nlm.nih.gov Primary source: https://www.phenxtoolkit.org/ Recent publication: Hendershot, T., Pan, H., Haines, J., Harlan, W.R., Marazita, M.L., McCarty, C.A., Ramos, E.M., and Hamilton, C.M. (2015) Using the PhenX toolkit to add standard measures to a study. Curr. Protoc. Hum. Genet. 86:1.21.1-1.21.17. doi: 10.1002/0471142905.hg0121s86 Permission to publish granted by Carol M. Hamilton.

HIS medical history - prostate prostate cancer - HIS

- 4/13/21 - 1 form, 7 itemgroups, 39 items, 2 languages
Itemgroups: Admininstrative Daten, Organspezifisch Prostata, Gewebebanking Einwilligung, Tumorspezifische Daten, Patientenbefragung, Score, EORTC Fragen
HIS form from Soarian. Urologie Erlangen" with friendly permission of the urology Erlangen (Prof. Wullich) and the medical informatics department Erlangen (PD Dr. Bürkle)

HIS medical history prostate cancer - HIS

- 8/7/13 - 1 form, 8 itemgroups, 70 items, 2 languages
Itemgroups: Admininstrative Daten, Studiendaten, Anamnese, Tumorerkrankungen, Tumordaten, klinischer TNM, Lokalisation von Fernmetastasen, Anamnese Historie
HIS form from Soarian. Urologie Erlangen" with friendly permission of the urology Erlangen (Prof. Wullich) and the medical informatics department Erlangen (PD Dr. Bürkle)

HIS medical history prostate cancer - HIS

- 5/15/13 - 1 form, 8 itemgroups, 70 items, 2 languages
Itemgroups: Admininstrative Daten, Studiendaten, Anamnese, Tumorerkrankungen, Tumordaten, klinischer TNM, Lokalisation von Fernmetastasen, Anamnese Historie
HIS medical history prostate cancer

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Baseline - CRFs Cabazitaxel Prostate Cancer NCT01308580 Baseline

- 5/12/17 - 1 form, 36 itemgroups, 232 items, 1 language
Itemgroups: Visit Information, Informed Consent, Demography, Informed Consent - Pharmacokinetic, Informed Consent - Pharmacogenomic, Informed Consent - Biomarker (cDNA), Cancer Diagnosis, Health Status, Bone Scan, Operation on prostate, Surgery for androgen ablation, Prior Radiation Therapy, Prior Chemotherapy, Medical or Surgical History, Renal Diseases and Risk, Medication - Nephrotoxicity, Vital Signs, Ophthalmologic Examination, Electrocardiogram, Laboratory Tests Hematology, Laboratory Tests Biochemisty, Urinanalysis, Blood sampling, Tumor Workup, Tumor Assessment - Target Lesions, Tumor Assessment - Non-target Lesion, Bone Scan, Tumor markers, Questionnaire for Cancer Pain, FACT-P Questionnaire, FACT-P Questionnaire: Physical Well-Being, FACT-P Questionnaire - Social/ Family Well-Being, FACT-P Questionnaire - Emotional Well-Being, FACT-P Questionnaire - Functional Well-Being, FACT-P Questionnaire - Additional Concerns, Eligibility for Randomization
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

HIS medical history breast cancer - HIS

- 8/7/13 - 1 form, 8 itemgroups, 108 items, 2 languages
Itemgroups: Patientenaufkleber groß, Anamnesebogen, Vorerkrankungen/Voroperationen, Externe Befunde, Familienanamnese, Klinischer Befund, Mammasonographie, Procedere
documentation standard - breast cancer - gynecology, with friendly permission (Dr. Tio) - kooperatives Brustzentrum Münster, Bereich Senologie an der Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Leitung: Dr. med. Joke Tio

HIS short medical history - cancer conference breast cancer - HIS

- 8/7/13 - 1 form, 5 itemgroups, 44 items, 2 languages
Itemgroups: Admininstrative Daten, Mini-Anamnese für Tumorkonferenz, klin. TNM-Stadium, vorhandenes path. TNM-Stadium, Anamnese
HIS form from Soarian. "Frauenklinik Erlangen" with friendly permission of the gynecology Erlangen (Prof. Beckmann) and the medical informatics department Erlangen (PD Dr. Bürkle)

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Disease History NCT00078572

- 5/29/17 - 1 form, 4 itemgroups, 48 items, 1 language
Itemgroups: Disease History Screening, Prior Anti-Cancer Surgery Screening, Prior Anti-Cancer Systemic Therapy Screening, Prior Anti-Cancer Radiotherapy Screening
Study ID: 100151 Clinical Study ID: EGF100151 Study Title: A Phase III, Randomized, Open-label, Multicenter Study Comparing GW572016 and Capecitabine (XELODA) versus Capecitabine in Women with Refractory Advanced or Metastatic Breast Cancer Clinicaltrials.gov Identifier: NCT00078572 https://clinicaltrials.gov/ct2/show/NCT00078572 Procedure: Disease History Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Breast Cancer; Neoplasms, Breast

PROGNOSTIC FACTORS Roche H0650g Breast Cancer - PROGNOSTIC FACTORS

- 9/20/21 - 1 form, 1 itemgroup, 26 items, 1 language
Itemgroup: Prognostic factors
Study part: Prognostic factors. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - Medical conditions

- 3/17/20 - 1 form, 3 itemgroups, 9 items, 1 language
Itemgroups: Administrative Data, Medical conditions, Medical conditions entry
Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document contains the medical conditions of the patient. It has to be filled in for screening.

CONCOMITANT MEDICATIONS Roche H0650g Breast Cancer - CONCOMITANT MEDICATIONS

- 5/29/17 - 1 form, 1 itemgroup, 1 item, 1 language
Itemgroup: Concomitant medication
Study part: Concomitant Medications. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

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