ClinicalTrials.gg
CompletedNCT03471572BRCAUpdated Dec 18, 2019

Study to Assess Prevalence of BRCA1 and BRCA2 Mutation Among Ovarian, Primary Peritoneal and Fallopian Tube Cancer Patients in India

An observational study in Ovarian Cancer, sponsored by AstraZeneca. Completed at 8 sites in India. Open to female participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2019-12-18.

Sponsored by AstraZeneca · Observational

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Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
240
Ages
18 Years to 130 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 70 studies in Ovarian Neoplasms by AstraZeneca — 8 open to participants now, 20 under way, 6 of them phase 3. Ovarian Neoplasms · AstraZeneca.

Enrollment
14th of 20
240 · median 378
Started
2018
with 5 others
Observational
20 of 70
1 open now
Registered
40th of 70
by date

Among the 70 studies in Ovarian Neoplasms by AstraZeneca, this one is the 14th largest by enrollment of the 20 observational ones that give a count, is one of 6 that started in 2018, is one of 20 observational ones, and was the 40th registered.

Ovarian Neoplasms

3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.

Browse Ovarian Neoplasms studies →

Open to participants now

8 of the 70 studies in Ovarian Neoplasms by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:

3 more — sign in →

By country, each count listing its studies:

All 8 open studies →

Who these studies take

Of the 605 Ovarian Neoplasms studies recruiting now, 442 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.

This study: 18 Years to 130 Years · female · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Ovarian Cancer

Keywords

  • BRCA, ovarian cancer, fallopian tube cancer
04

Who can participate

Ages eligible
18 Years to 130 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Previously or newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer patients.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patient with any medical condition that, in the opinion of the investigator, would interfere with safe completion of the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
240 participants (actual)
Patient registry
No

Groups and cohorts

  • 1

    Ovarian Cancer

06

What researchers measure

Primary outcomes

  1. BRCA1 or BRCA2 mutation positive status

    ENIGMA (Evidence-based Network for the Interpretation of Germline Mutant Alleles)

    Time frame: 1 day

Secondary outcomes

  1. 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.

    Time frame: 1 Day

07

Study locations

8 sites
  • Research Site
    Bangalore, Karnataka 560027, India
  • Research Site
    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
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Dec 2018, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 14, 2018
First posted
Mar 20, 2018
StartActual
Mar 22, 2018
Primary completionActual
Dec 21, 2018
CompletionActual
Dec 21, 2018
Last update
Dec 18, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03471572
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Mar 20, 2018
Start date
Mar 22, 2018
Primary completion
Dec 21, 2018
Completion
Dec 21, 2018
Last update
Dec 18, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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