Clinical trial NCT03471572: Study to Assess Prevalence of BRCA1 and BRCA2 Mutation Among Ovarian, Primary Peritoneal and Fallopian Tube Cancer Patients in India
Official title: A Non-interventional, Multicentre Study to Assess Prevalence of BRCA1 and BRCA2 Mutation Among Ovarian, Primary Peritoneal and Fallopian Tube Cancer Patients in India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: BRCA, ovarian cancer, fallopian tube cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-03-20
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously or newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer patients.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients who provide written informed consent
2. Female ≥ 18 years of age
3. Previously or newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer patients.

Exclusion Criteria:

1. Patient with any medical condition that, in the opinion of the investigator, would interfere with safe completion of the study

Primary outcomes:
measure: BRCA1 or BRCA2 mutation positive status
timeFrame: 1 day
Secondary outcomes:
measure: Association between histopathological type and BRCA 1/BRCA 2 mutation positive status
timeFrame: 1 Day
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Delhi
country: India
facility: Research Site
state: New Delhi
city: Delhi
country: India
facility: Research Site
state: New Delhi
city: Delhi
country: India
facility: Research Site
state: New Delhi
city: Hyderabad
country: India
facility: Research Site
state: Telangana
city: Kolkata
country: India
facility: Research Site
state: West Bengal
Study officials:
References: