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AzTrials

Cervical Cancer ScreeningNCG-ComplianceNCT07290972

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

An observational study of Cervical Cancer Screening and Gynecologic Cancers, run by Tata Memorial Hospital at 2 sites in India.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
What is being tested?
Not applicable- observational study
How many people
618 participants
Where
2 sitesIndia
Study dates
1 Feb 2021to 31 Mar 2026
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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.

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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dr. Supriya Chopra, MD contact

9930958309

supriyasastri@gmail.com

India2 sites, 2 recruiting
  • Tata Memorial Hospital

    Mumbai, Maharashtra, 400012

    Dr. Supriya Chopra, MD, 9930958309, supriyasastri@gmail.com

    Recruiting
  • Tata Memorial Hospital

    Mumbai, Maharashtra, 400012

    Dr Supriya Chopra, MD, +91 9930958309, supriyasastri@gmail.com

    Recruiting

Other trials in India

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Not applicable- observational study
Keywords
Cervical cancer, Cancer, Recurrence, Treatment, Compliance, Chemoradiotherapy
Medical subject headings
Patient Compliance, Uterine Cervical Neoplasms, Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Not applicable- observational studyOther

    Compliance to Cervical Cancer Chemoradiation treatment guidelines

Study groups in NCT07290972
Study groupRoleWhat they receive
Patients diagnosed with Cervical CancerPatients diagnosed with histologically proven cervical cancer wherein either radical, adjuvant or palliative radiation with or without concurrent or systemic chemotherapy planned.
Receives: Other: Not applicable- observational study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. report on institutional compliance to National Cancer Grid cervical cancer guidelines for chemo-radiation.

    To report praportion of patients with No deviation, Major \& Minor Deviation and unacceptable deviation for chemoradiation guidlines.

    Measured: 3 Months

Secondary outcomes (3)
  1. To report on factors impacting compliance to standard guidelines

    Measured: 3years

  2. To report adequacy of infrastructural and manpower requirements for optimal treatment of cervical cancer in NCG centres and corresponding state of origin

    Measured: 3 years

  3. To compute relative risk of suboptimal treatment for cervical cancer in reference to infrastructural and manpower deficits

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start1 Feb 2021
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
618 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07290972
Sponsor's protocol ID
TMC IEC III 900537
Acronym
NCG-Compliance
Status last verified
Jan 2026
First submitted
21 Aug 2025
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Dr. V. K. Srivastava, Dr Tanvir Kaur, Dr. S Shrisvastava () CONSENSUS DOCUMENT FOR THE MANAGEMENT OF CANCER CERVIX, Available at: https://www.icmr.nic.in > sites > default > files > reports > Cervix Cance (Accessed: 12th December 2019).

  • IAEA staffing estimator. http://nucleus.iaea.org/HHW/RadiationOncology/making the case for radiotherapy in your country/role of radiotherapy in cancer care/radiotherapy is a cost effective system which needs balance/index.html.

  • IPEM recommendations for the provision of physics services to radiotherapy. http://ipem.ac.uk/portals/0/documents/recommendations.

  • Budiharto T, Musat E, Poortmans P, Hurkmans C, Monti A, Bar-Deroma R, Bernstein Z, Tienhoven Gv, Collette L, Duclos F, Davis B, Aird E; EORTC Radiation Oncology Group. Profile of European radiotherapy departments contributing to the EORTC Radiation Oncology Group (ROG) in the 21st century. Radiother Oncol. 2008 Sep;88(3):403-10. doi: 10.1016/j.radonc.2008.05.013. Epub 2008 Jun 4.

    PubMed 18538427
  • International Atomic Energy Agency. Planning national radiotherapy services: a practical tool. IAEA human health series number 14. Vienna International Atomic Energy Agency;2010. ISBN 978-92-0-1059 10-9.

  • Nandakumar A, Kishor Rath G, Chandra Kataki A, Poonamalle Bapsy P, Gupta PC, Gangadharan P, Mahajan RC, Nath Bandyopadhyay M, Kumaraswamy, Vallikad E, Visweswara RN, Selvaraj Roselind F, Sathishkumar K, Daniel Vijaykumar D, Jain A, Lakshminarayana Sudarshan K. Concurrent Chemoradiation for Cancer of the Cervix: Results of a Multi-Institutional Study From the Setting of a Developing Country (India). J Glob Oncol. 2015 Sep 23;1(1):11-22. doi: 10.1200/JGO.2015.000877. eCollection 2015 Oct.

    PubMed 28804767
  • Grover S, Gudi S, Gandhi AK, Puri PM, Olson AC, Rodin D, Balogun O, Dhillon PK, Sharma DN, Rath GK, Shrivastava SK, Viswanathan AN, Mahantshetty U. Radiation Oncology in India: Challenges and Opportunities. Semin Radiat Oncol. 2017 Apr;27(2):158-163. doi: 10.1016/j.semradonc.2016.11.007. Epub 2016 Nov 14.

    PubMed 28325242
  • Banerjee S, Mahantshetty U, Shrivastava S. Brachytherapy in India - a long road ahead. J Contemp Brachytherapy. 2014 Oct;6(3):331-5. doi: 10.5114/jcb.2014.45761. Epub 2014 Oct 6.

    PubMed 25337139
  • Gandhi AK, Sharma DN, Julka PK, Rath GK. Attitude and practice of brachytherapy in India: a study based on the survey amongst attendees of Annual Meeting of Indian Brachytherapy Society. J Contemp Brachytherapy. 2015 Dec;7(6):462-8. doi: 10.5114/jcb.2015.55666. Epub 2015 Nov 17.

    PubMed 26816503
  • Mittal P, Chopra S, Pant S, Mahantshetty U, Engineer R, Ghosh J, Gupta S, Ghadi Y, Menachery S, Swamidas J, Gurram L, Shrivastava SK. Standard Chemoradiation and Conventional Brachytherapy for Locally Advanced Cervical Cancer: Is It Still Applicable in the Era of Magnetic Resonance-Based Brachytherapy? J Glob Oncol. 2018 Jul;4:1-9. doi: 10.1200/JGO.18.00028.

    PubMed 30085892
  • Mahantshetty U, Krishnatry R, Hande V, Jamema S, Ghadi Y, Engineer R, Chopra S, Gurram L, Deshpande D, Shrviastava S. 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. Int J Radiat Oncol Biol Phys. 2017 Nov 1;99(3):608-617. doi: 10.1016/j.ijrobp.2017.06.010. Epub 2017 Jun 20.

    PubMed 29280456
  • Prescribing, Recording, and Reporting Brachytherapy for Cancer of the Cervix. J ICRU. 2013 Apr;13(1-2):NP. doi: 10.1093/jicru/ndw027. No abstract available.

    PubMed 27335496
  • Sturdza A, Potter R, Fokdal LU, Haie-Meder C, Tan LT, Mazeron R, Petric P, Segedin B, Jurgenliemk-Schulz IM, Nomden C, Gillham C, McArdle O, Van Limbergen E, Janssen H, Hoskin P, Lowe G, Tharavichitkul E, Villafranca E, Mahantshetty U, Georg P, Kirchheiner K, Kirisits C, Tanderup K, Lindegaard JC. Image guided brachytherapy in locally advanced cervical cancer: Improved pelvic control and survival in RetroEMBRACE, a multicenter cohort study. Radiother Oncol. 2016 Sep;120(3):428-433. doi: 10.1016/j.radonc.2016.03.011. Epub 2016 Apr 29.

    PubMed 27134181
  • Potter R, Tanderup K, Kirisits C, de Leeuw A, Kirchheiner K, Nout R, Tan LT, Haie-Meder C, Mahantshetty U, Segedin B, Hoskin P, Bruheim K, Rai B, Huang F, Van Limbergen E, Schmid M, Nesvacil N, Sturdza A, Fokdal L, Jensen NBK, Georg D, Assenholt M, Seppenwoolde Y, Nomden C, Fortin I, Chopra S, van der Heide U, Rumpold T, Lindegaard JC, Jurgenliemk-Schulz I; EMBRACE Collaborative Group. The EMBRACE II study: The outcome and prospect of two decades of evolution within the GEC-ESTRO GYN working group and the EMBRACE studies. Clin Transl Radiat Oncol. 2018 Jan 11;9:48-60. doi: 10.1016/j.ctro.2018.01.001. eCollection 2018 Feb.

    PubMed 29594251
  • Gupta S, Maheshwari A, Parab P, Mahantshetty U, Hawaldar R, Sastri Chopra S, Kerkar R, Engineer R, Tongaonkar H, Ghosh J, Gulia S, Kumar N, Shylasree TS, Gawade R, Kembhavi Y, Gaikar M, Menon S, Thakur M, Shrivastava S, Badwe R. Neoadjuvant Chemotherapy Followed by Radical Surgery Versus Concomitant Chemotherapy and Radiotherapy in Patients With Stage IB2, IIA, or IIB Squamous Cervical Cancer: A Randomized Controlled Trial. J Clin Oncol. 2018 Jun 1;36(16):1548-1555. doi: 10.1200/JCO.2017.75.9985. Epub 2018 Feb 12.

    PubMed 29432076

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Cancer Screening and Gynecologic Cancers, run by Tata Memorial Hospital at 2 sites in India.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr. Supriya Chopra, MD (9930958309, supriyasastri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

report on institutional compliance to National Cancer Grid cervical cancer guidelines for chemo-radiation. (time frame: 3 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07290972, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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