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

February 3, 2026 updated by: Supriya Sastri (chopra), Tata Memorial Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

618

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Recruiting
        • Tata Memorial hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The participating centers that agree to contribute data will include all registered cases over a 6 month period that have been diagnosed with histologically proven cervical cancer wherein either radical, adjuvant or palliative radiation with or without concurrent or systemic chemotherapy is planned.

Furthermore any cases referred to the institution for brachytherapy alone will also be included.

Description

The participating centers that agree to contribute data will include all registered cases over a 6 month period that have been diagnosed with histologically proven cervical cancer wherein either radical, adjuvant or palliative radiation with or without concurrent or systemic chemotherapy is planned.

Furthermore any cases referred to the institution for brachytherapy alone will also be included.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients diagnosed with Cervical Cancer
Patients diagnosed with histologically proven cervical cancer wherein either radical, adjuvant or palliative radiation with or without concurrent or systemic chemotherapy planned.
Other: Not applicable- observational study
Compliance to Cervical Cancer Chemoradiation treatment guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
report on institutional compliance to National Cancer Grid cervical cancer guidelines for chemo-radiation.
Time Frame: 3 Months
To report praportion of patients with No deviation, Major & Minor Deviation and unacceptable deviation for chemoradiation guidlines.
3 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
To report on factors impacting compliance to standard guidelines
Time Frame: 3years
3years
To report adequacy of infrastructural and manpower requirements for optimal treatment of cervical cancer in NCG centres and corresponding state of origin
Time Frame: 3 years
3 years
To compute relative risk of suboptimal treatment for cervical cancer in reference to infrastructural and manpower deficits
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Hospital

Collaborators

Christian Medical College, Vellore, India
Post Graduate Institute of Medical Education and Research, Chandigarh
MNJ Institute of Oncology and Regional Cancer Center

Investigators

  • Principal Investigator: Dr. Supriya Chopra, MD, ACTREC, Tata Memorial Centre, Navi Mumbai India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

August 21, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMC IEC III 900537

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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