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This is a non-interventional, cross-sectional, multicentre, observational study planned to be conducted at 15 sites across all geographical regions of India. The study targets to enrol 240 patients with approximately 16 patients from each site. Written approval of Independent Ethics Committee (IEC)/ Institutional Review Board (IRB) and written informed consent from willing patients will be obtained prior to the start of the study.
This is a non-interventional, cross-sectional, multicentre, observational study to be conducted at 15 sites from different geographical regions across India. The study targets to enrol 240 patients with nearly 16 patients per site over 6 months. The study will enrol females with diagnosis of ovarian, primary peritoneal, or fallopian tube cancer. No study medication will be prescribed or administered as a part of study procedure.
The study will start only after obtaining written approval of Independent Ethics Committee (IEC) / Institutional Review Board (IRB) and written informed consent of the patient.
The study will start only after obtaining written approval of Independent Ethics Committee (IEC) / Institutional Review Board (IRB) and written informed consent of the patient. Eligible patients will undergo physical examination and data of demographics, vital signs, present/ past history of illness, family history of breast/ovarian cancer, current and previous chemotherapy regimen and current medication will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Ovarian Cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| BRCA1 or BRCA2 mutation positive status | ENIGMA (Evidence-based Network for the Interpretation of Germline Mutant Alleles) | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Association between histopathological type and BRCA 1/BRCA 2 mutation positive status | Frequency of different histopathological type and BRCA 1/BRCA 2 mutation positive status will be presented. | 1 Day |
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Inclusion Criteria:
Exclusion Criteria:
1. Patient with any medical condition that, in the opinion of the investigator, would interfere with safe completion of the study
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Previously or newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer patients.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bangalore | Karnataka | 560027 | India | ||
| Research Site |
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| Label | URL |
|---|---|
| Redacted\_csr\_synopsis | View source |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| Mumbai |
| Maharashtra |
| 400012 |
| India |
| Research Site | Mumbai | Maharashtra | 400071 | India |
| Research Site | Delhi | New Delhi | 110005 | India |
| Research Site | Delhi | New Delhi | 110017 | India |
| Research Site | Delhi | New Delhi | 110060 | India |
| Research Site | Hyderabad | Telangana | 500034 | India |
| Research Site | Kolkata | West Bengal | 700099 | India |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |