India HIV-CervCa Project

NCT07167069 | Active Not Recruiting

• 3 other identifiers: UPCC 20824834664DAA3-19-65331-1
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Positive; HIV Negative; Cervical Cancer

Keywords

Chemotherapy; Concurrent Chemoradiotherapy; Radiotherapy

Outcome Measures

Primary Outcomes (2)

• Completion Rates of Cancer Treatment

  To evaluate and compare the completion rates of cancer treatment in HIV positive cervical cancer patients and HIV negative cervical cancer patients. Treatment adherence is defined as receiving at least 5 cycles of weekly cisplatin chemotherapy and completion of all prescribed radiation (including brachytherapy) and chemotherapy within 8 weeks of treatment initiation.

  2 years

• Impact of HIV Infection on acute toxicities

  To compare the incidence of acute grade ≥3 gastrointestinal, genitourinary and hematological toxicities using CTCAE v4 in patients receiving concurrent cisplatin-based chemo-radiation and brachytherapy for cervical cancer in HIV positive and HIV negative patients. Acute toxicities include any toxicity occurring within 90 days of treatment completion.

  2 years

Secondary Outcomes (1)

• Tumor infiltrating lymphocytes (TILs)

  2 Years

Study Arms (2)

HIV Positive

Cervical Cancer Patients with HIV positive

Radiation: Radiation Therapy

HIV Negative

Cervical Cancer Patients with HIV negative

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

Standard of Care Chemoradiation for Cervical cancer patients in India.

HIV Negative; HIV Positive

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with cervical cancer at Tata Memorial Hospital in India.

You may qualify if:

• 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

You may not qualify if:

• patients with active tuberculosis

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Tata Memorial Hospital: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy specimens collected for Tumor-Infiltrating Lymphocytes (TILs) detection.

MeSH Terms

Conditions

HIV Seropositivity; Uterine Cervical Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Surbhi Grover, MD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 11, 2025
• Study Start: February 9, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)