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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03471572
Other study ID # D0818R00001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 22, 2018
Est. completion date December 21, 2018

Study information

Verified date December 2019
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date December 21, 2018
Est. primary completion date December 21, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 130 Years
Eligibility 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

Study Design


Locations

Country Name City State
India Research Site Bangalore Karnataka
India Research Site Delhi New Delhi
India Research Site Delhi New Delhi
India Research Site Delhi New Delhi
India Research Site Hyderabad Telangana
India Research Site Kolkata West Bengal
India Research Site Mumbai Maharashtra
India Research Site Mumbai Maharashtra

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary BRCA1 or BRCA2 mutation positive status ENIGMA (Evidence-based Network for the Interpretation of Germline Mutant Alleles) 1 day
Secondary 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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