NCT07290972

Compliance to Cervical Cancer Chemoradiation Guidelines: A Multicentric Implementation Audit and Resource Assessment Initiative of National Cancer Grid of India

Compliance to Cervical Cancer Chemoradiation Guidelines: A Implementation Audit and Resource Assessment Initiative of National Cancer Grid of India

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 618 (estimated)
• Sponsor: Tata Memorial Hospital · Other Government
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a combination of retrospective and prospective observational study that will be performed across NCG and other participating centers to report compliance to chemoradiation for cervical cancer. This audit will include patients treated with standard of care treatment, in this case definitive or adjuvant radiation+/- concurrent chemotherapy will be included. Patients recruited in various institutions in prospective clinical trials will not be included. The participating centersthat agree to contribute data will include all registered cases over a 6-month period that have been diagnosed with cervical cancer wherein treatment is planned with radical dose radiation and/or concurrent chemotherapy. Centers that do not have retrospective data of the patients will contribute data of patients registered prospectively over 6 months. Furthermore, any cases referred to the institution for brachytherapy alone will also be included. As a first step member institutions that participated in guideline development process or provide an agreement to guidelines adherence will be audited. The project will be submitted in institutional ethics committees with memorandum of understanding for anonymized data sharing. Each of the co-investigators listed from contributing centers will be directly responsible for collecting data contribution and accuracy of data submitted. Those centres which cannot or do not want to participate will be requested to provide data on only compliance outcomes to treatment for at least of 5 consecutively patients diagnosed with cervical cancer wherein treatment is planned with radical dose radiation and /or concurrent chemotherapy over a period of 6 months.

Detailed description

Investigator intend to use electronic case record form (e-CRF) created using on line portal (google e-forms) wherein details of patients treated within the 6 month period will be captured. Google e-CRF will be available to all participating centres free of charge and has ease of access for filling details on both computer, tablets or mobile phone platforms. The e-form is user friendly and provides automated excel output and basic trends of responses and is ideal to be used across busy departments and low resource settings. To maintain data security, no patient identifying information will be collected. Each institution will be provided an institution id and name identifiers will not be used. Similarly a code will be generated for each of the patient and details of that code will remain with the parent institution.

Conditions

• Cervical Cancer Screening
• Gynecologic Cancers
• Treatment Compliance
• Chemoradiotherapy

Interventions

Type	Name	Description
OTHER	Not applicable- observational study	Compliance to Cervical Cancer Chemoradiation treatment guidelines

Timeline

• Start date: 2021-02-01
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2025-12-18
• Last updated: 2026-02-04

Locations

2 sites across 1 country: India