India HIV-CervCa Project

NCT ID: NCT07167069

Last Updated: 2025-09-11

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

ACTIVE_NOT_RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-09

Study Completion Date

2026-05-31

Brief Summary

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The investigators propose to prospectively study the difference in treatment (CTRT) completion and toxicities between HIV positive and HIV negative women in India with locally advanced cervical cancer receiving CTRT.

Detailed Description

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This study will compare chemoradiation completion rates for cervical cancer in two groups, women with HIV and women without HIV. The investigators will also be analyzing tumor tissue for tumor infiltrating lymphocytes which are thought to be involved in disease progression.

Conditions

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HIV Positive HIV Negative Cervical Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV Positive

Cervical Cancer Patients with HIV positive

Radiation Therapy

Intervention Type RADIATION

Standard of Care Chemoradiation for Cervical cancer patients in India.

HIV Negative

Cervical Cancer Patients with HIV negative

Radiation Therapy

Intervention Type RADIATION

Standard of Care Chemoradiation for Cervical cancer patients in India.

Interventions

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Radiation Therapy

Standard of Care Chemoradiation for Cervical cancer patients in India.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* patients with newly biopsy proven squamous carcinoma or adenocarcinoma of the uterine cervix, FIGO stage IB2-IIIB in whom curative CTRT is planned
* Karnofsky performance status ≥ 70
* Patients with lower paraortic lymph nodes (below the level of L2 vertebra)
* patients diagnosed with cervical cancer whom also HIV positive or HIV negative

Exclusion Criteria

* patients with active tuberculosis
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tata Memorial Hospital

OTHER_GOV

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Surbhi Grover, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Tata Memorial Hospital

Mumbai, Maharashtra, India

Site Status

Countries

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India

Other Identifiers

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834664

Identifier Type: OTHER

Identifier Source: secondary_id

DAA3-19-65331-1

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 20824

Identifier Type: -

Identifier Source: org_study_id

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