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

NCT ID: NCT03471572

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-22

Study Completion Date

2018-12-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ovarian Cancer

Keywords

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BRCA, ovarian cancer, fallopian tube cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Ovarian Cancer

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Bangalore, Karnataka, India

Site Status

Research Site

Mumbai, Maharashtra, India

Site Status

Research Site

Mumbai, Maharashtra, India

Site Status

Research Site

Delhi, New Delhi, India

Site Status

Research Site

Delhi, New Delhi, India

Site Status

Research Site

Delhi, New Delhi, India

Site Status

Research Site

Hyderabad, Telangana, India

Site Status

Research Site

Kolkata, West Bengal, India

Site Status

Countries

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India

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D0818R00001&attachmentIdentifier=1d220cab-775e-4bad-bee4-a1d76d7f4c1f&fileName=redacted_csr_synopsys_BRCA_study.pdf&versionIdentifier=

Redacted\_csr\_synopsis

Other Identifiers

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D0818R00001

Identifier Type: -

Identifier Source: org_study_id