Comparing of treatment given and harm caused in HIV positive v/s HIV negative cervical cancer patients in India.

Not Applicable

• Conditions: Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified

• Registration Number: CTRI/2022/02/040584
• Lead Sponsor: CRDF Global

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients with newly biopsy proven squamous carcinoma or adenocarcinoma of the uterine cervix, FIGO stage IB2-IIIB in whom curative CTRT is planned.

2. Patients with lower paraortic lymph nodes (below the level of L2 vertebra) would be included in the study.

3. Staging would include clinical examination, CT/MR imaging of the abdomen and pelvis and chest radiography.

4. All patients would undergo baseline blood investigations, which include complete blood count (CBC), renal function tests, liver functions test and viral marker testing which include HIV, Hepatitis B and Hepatitis C.

5. Patients with pre-existing HIV positive status will have CD4 counts and HIV viral load evaluated prior to the initiation of cancer directed therapy.

6. Report of CD4 counts done within the prior 6 months of initiating treatment would be accepted. Patients with newly detected HIV positive status would be counseled and directed to HAART clinic, and CD4 counts/ HIV viral load will be evaluated prior to initiation of HAART and cancer treatment.

7. Additional eligibility criteria include: age >= 18 years, Karnofsky performance status >= 70.

Exclusion Criteria

1. Patients with active tuberculosis, which would preclude curative treatment or history of previous malignancy.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the treatment adherence to concurrent chemo-radiation (CTRT) in HIV positive cervical cancer patients with HIV negative cervical cancer patients: <br/ ><br>a) To evaluate and compare the completion rates of cancer treatment in HIV positive cervical cancer patients and HIV negative cervical cancer patients. <br/ ><br>b) To study the impact of HIV infection on acute toxicities in patients receiving radiation and concurrent cisplatin chemotherapy for cervical cancer.Timepoint: 6 weeks post treatment and then every 3 months up to 2 years.

Secondary Outcome Measures

Name	Time	Method
To identify and characterize tumor infiltrating lymphocytes (TILs) with reference to numbers and phenotype in tumor biopsies of HIV positive and HIV negative cervical cancer patients.Timepoint: Once before treatment start