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  1. 1. Essai clinique
  2. 2. Routinedokumentation
  3. 3. Études de registres/cohortes
  4. 4. Assurance qualité
  5. 5. Standard de données
  6. 6. Questionnaire pour les patients
  7. 7. Spécialité médicale
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On-Study - Primary Ovarian Cancer - On-Study Form - 2019341v2.31 - Primary Ovarian Cancer - On-Study Form

- 08/01/2015 - 1 Formulaire, 6 Groupes Item, 39 Eléments de données, 1 Langue
Groupes Item: 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

NCT00954174 On-Study - GOG-0261: Primary Ovarian Cancer - On Study Form - 3072737v1.0 - GOG-0261: Primary Ovarian Cancer - On Study Form

- 09/01/2015 - 1 Formulaire, 5 Groupes Item, 26 Eléments de données, 1 Langue
Groupes Item: HEADER MODULE, OVARIAN: DISEASE DESCRIPTION, OVARIAN: FINDINGS FROM PRIMARY SURGERY, OVARIAN: POST-OPERATIVE FINDINGS FOLLOWING PRIMARY SURGERY, COMMENTS
GOG-0261: Primary Ovarian Cancer - On Study Form 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=84C04E8A-314B-D474-E040-BB89AD435DDB

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)

- 09/01/2015 - 1 Formulaire, 5 Groupes Item, 32 Eléments de données, 1 Langue
Groupes Item: 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

Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612 - Study End

- 13/08/2019 - 1 Formulaire, 3 Groupes Item, 8 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Clinical Research, End, Investigator Signature, Confirmation
Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: HycamtinTM Study Indication: Ovarian Cancer

HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173 - Study Conclusion

- 12/07/2019 - 1 Formulaire, 2 Groupes Item, 5 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Conclusion, Clinical Research
Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612 - Follow-Up

- 20/11/2019 - 1 Formulaire, 9 Groupes Item, 29 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Follow-up, Month, Clinical Trials, Result, X-Ray Computed Tomography, Tumor Markers, follow-up visit date, Response to treatment, Evaluation, Therapeutic procedure, Other, Investigator Signature
Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: HycamtinTM Study Indication: Ovarian Cancer

Ovarian Cancer NCT00993655 Follow-Up - NCIC OV 21 Follow-Up Report Form - 2874229v1.0 - NCIC OV 21 Follow-Up Report Form

- 09/01/2015 - 1 Formulaire, 14 Groupes Item, 60 Eléments de données, 1 Langue
Groupes Item: Patient Information, TIMING OF REPORT, PHYSICAL EXAM, RESPONSE ASSESSMENT - QUESTION 2, TARGET LESIONS, NON-TARGET LESIONS DURING TREATMENT, NEW LESIONS, RADIOLOGY, CA 125 - TABLE, ADVERSE EVENTS / INTERCURRENT ILLNESS, ANTI-CANCER TREATMENT, QUALITY OF LIFE QUESTIONNAIRE, Comments, Contact Information
NCIC OV 21 Follow-Up Report Form Comparing Three Combination Chemotherapy Regimens in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=69B8C40D-B83D-E610-E040-BB89AD43211A

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

- 29/06/2023 - 3 Formulaires, 1 Groupe Item, 5 Eléments de données, 1 Langue
Groupe Item: 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 Groupe Item 79 Eléments de données

Eligibility

1 Groupe Item 2 Eléments de données

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

- 02/04/2024 - 5 Formulaires, 1 Groupe Item, 5 Eléments de données, 1 Langue
Groupe Item: 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 Groupe Item 3 Eléments de données

pht004640.v1.p1

1 Groupe Item 5 Eléments de données

Eligibility

1 Groupe Item 2 Eléments de données

pht004639.v1.p1

1 Groupe Item 50 Eléments de données

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

- 09/01/2015 - 1 Formulaire, 3 Groupes Item, 24 Eléments de données, 1 Langue
Groupes Item: 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 NCT00993655 On-Study - NCIC OV 21 Relapse-Progression Report Form - 2874242v1.0 - NCIC OV 21 Relapse-Progression Report Form

- 09/01/2015 - 1 Formulaire, 9 Groupes Item, 34 Eléments de données, 1 Langue
Groupes Item: Patient Information, TYPE OF PROGRESSION, DATE OF CA125 PROGRESSION, DISEASE STATUS AT RELAPSE-PROGRESSION, TARGET LESIONS, NON-TARGET LESIONS, NEW LESIONS, Comments, Contact Information
NCIC OV 21 Relapse-Progression Report Form Comparing Three Combination Chemotherapy Regimens in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=69B8C40D-B857-E610-E040-BB89AD43211A

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course -- (Day 1) - Eligibility; Vital Signs; Administration of Study Medications

- 02/09/2019 - 1 Formulaire, 6 Groupes Item, 45 Eléments de données, 1 Langue
Groupes Item: Administrative, Eligibility, Vital Signs, Administration of Study Medications, Topotecan Administration, Gemcitabine Administration
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

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