Development of blood tests for early detection and treatment monitoring of cervical cancer

Completed

• Conditions: Malignant neoplasm of cervix uteri, unspecified,

• Registration Number: CTRI/2020/01/022862
• Lead Sponsor: DBT Ramalingaswamy Fellowship

Brief Summary

The current study aims to test if a digital PCR based assay for detection of HPV in circulating tumor DNA (ctDNA) is a sensitive and a sustainable tool for early detection of CIN2 and CIN3 cervical cancer. Treatment monitoring and detection of minimal residual disease in more invasive HPV associated cancers.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-20
• Last Update Posted: 2021-03-13
• Study Completion: 2024-09-27

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Inclusion criteria includes Patients 18 years old or older with suspicion of cervical cancer referred to Manipal Comprehensive Cancer Center.

Exclusion Criteria

Patients diagnosed with inflammatory or haematological disease after the age of 18 will be excluded from the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The primary outcome is to measure the percentage of cervical cancers that can be detected using a liquid biopsy. Samples from follow up timepoints will be useful for analysis of treatment and their prognostic value for success of brachytherapy.	0, 3, 6 months. Follow up at 36 months.
2.Measure recurrence in cervical cancer patients through serial monitoring with liquid biopsies (blood sample).	0, 3, 6 months. Follow up at 36 months.
3.Identification of novel cervical cancer susceptible genes or genetic markers in the Indian population.	0, 3, 6 months. Follow up at 36 months.

Secondary Outcome Measures

Name	Time	Method
Identification of novel cervical cancer susceptible genes or genetic markers in the Indian population.	Pretreatment sample

Trial Locations

Locations (1)

Kasturba Hospital; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Hospital

🇮🇳Udupi, KARNATAKA, India

Rama Rao Damerla

Principal investigator

9989955566

rama.damerla@manipal.edu