Actively Recruiting

FEMALE
ID07290972

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

Led by Tata Memorial Hospital · Updated on 2026-02-04

618

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

T

Tata Memorial Hospital

Lead Sponsor

P

Post Graduate Institute of Medical Education and Research, Chandigarh

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a combined retrospective and prospective observational study across multiple centers to assess how well patients with cervical cancer follow recommended chemoradiation treatment guidelines. This research focuses on patients treated with standard care involving definitive or adjuvant radiation, with or without concurrent chemotherapy. The study excludes patients enrolled in other prospective clinical trials and emphasizes data collection from centers that agree to participate and contribute anonymized patient information. The study uses an electronic case record form (e-CRF) accessible via an online portal compatible with computers, tablets, and mobile devices. Participating centers will record details of all registered cervical cancer cases over a six-month period, including those planned for radical, adjuvant, or palliative radiation with or without chemotherapy. Cases referred solely for brachytherapy are also included. Data security is ensured by assigning institution IDs and anonymizing patient codes. Participants' involvement consists of data collection by co-investigators at each center, focusing on compliance to cervical cancer chemoradiation guidelines. The primary outcome measured is the institutional compliance report within three months. Secondary outcomes include factors affecting compliance, assessment of infrastructure and staffing adequacy, and calculation of risks associated with suboptimal treatment over three years. The total study duration extends until March 2026, during which centers will contribute data and monitor compliance trends.

CONDITIONS

Brief Title

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

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Registered cases diagnosed with histologically proven cervical cancer
  • Planned treatment includes radical, adjuvant, or palliative radiation
  • Treatment may include concurrent or systemic chemotherapy
  • Cases referred for brachytherapy alone are also included
  • Data collected over a 6-month period at participating centers
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Monitoring

Duration - 6 months

Participants who undergo routine care for cervical cancer are observed to assess compliance to chemo-radiation treatment guidelines and resource availability across centers.

Data is collected during treatment visits over a 6-month period

Long-term Monitoring

Duration - Up to 3 years

Participants are observed for up to 3 years to report on factors impacting guideline compliance, infrastructural adequacy, and treatment outcomes.

Follow-up data collection aligned with standard care visits

Trial Site Locations

Total: 2 locations

1

Tata Memorial Hospital

Mumbai, Maharashtra, India, 400012

Actively Recruiting

2

Tata Memorial Hospital

Mumbai, Maharashtra, India, 400012

Actively Recruiting

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Research Team

D

Dr. Supriya Chopra, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Frequently Asked Questions

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Magnetic Resonance Image Guided Adaptive Brachytherapy in Locally Advanced Cervical Cancer: An Experience From a Tertiary Cancer Center in a Low and Middle Income Countries Setting.

Umesh Mahantshetty, Rahul Krishnatry, Vinod Hande...

https://pubmed.ncbi.nlm.nih.gov/29280456

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https://pubmed.ncbi.nlm.nih.gov/27134181

The EMBRACE II study: The outcome and prospect of two decades of evolution within the GEC-ESTRO GYN working group and the EMBRACE studies.

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