Breast CancerTBCSNCT05301296
Trivandrum Breast Cancer Screening Trial
A study testing Clinical examination of the breast for early detection of Cancer in people with Breast Cancer, run by International Agency for Research on Cancer.
Trial summary
Cluster-randomized controlled trial in Trivandrum district, Kerala, India to evaluate the effect of triennial screening for breast cancer using clinical breast examination on breast cancer mortality. Read more about this study
- Who is it for?
- Ages 30 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Clinical examination of the breast for early detection of Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115,290 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Residing in 274 study clusters in Trivandrum City, Kerala
Who cannot join
- Diagnosis with breast cancer prior to study
- Bedridden subjects
- Subjects suffering from open tuberculosis or other debilitating diseases
About this study
Official title: Evaluating of Clinical Early Detection of Breast Cancer in Trivandrum District, India
Cluster-randomized controlled trial in Trivandrum district, Kerala, India to evaluate the effect of triennial screening for breast cancer using clinical breast examination on breast cancer mortality.
Read the detailed description
The study population consisted of 274 administrative regions (clusters) in Trivandrum district, Kerala, southern Indian. 133 clusters were randomly assigned to the intervention arm (3 rounds of clinical breast examination conducted 3 years apart) and were compared to the remaining 141 clusters assigned to a control arm that received standard of care. The eligibility criteria were all healthy subjects aged 30 to 69, without a personal history of breast cancer. Informed consent was signed by each participant. The intervention arm consisted of 55,843 participants and the control group consisted of 59,447 participants.
- Conditions
- Breast Cancer
- Being tested
- Clinical examination of the breast for early detection of Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examination of the breast for early detection of CancerDiagnostic test
Participants were invited for 3 rounds of clinical breast examination, conducted 3-years apart. Screening was conducted by health workers trained to perform clinical breast examination for early detection of cancer. Women with abnormal referable lesions underwent CBE by a trained clinician and those women with a confirmed breast lump or any other breast abnormality warranting further investigations were evaluated by triple-testing involving expert physical examination, diagnostic mammography with or without ultrasonography and fine needle aspiration cytology (FNAC) or core biopsy or excision biopsy. Those with confirmed breast cancer were referred for appropriate treatment with surgery, radiotherapy, and/or chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Standard of Care. |
| Intervention Arm | Active comparator | Clinical examination of the breast for early detection of Cancer. Receives: Diagnostic Test: Clinical examination of the breast for early detection of Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Cancer Death Rate
Information on all deaths were collected from the municipal and district death registers, hospital medical records, death records of churches and mosques, hospital visits by the population cancer registry staff and by project health workers. Cancer cases were coded by the ICD-O 3rd edition codes and cause of death was coded using ICD-10 by the registry and project staff blinded to study group allocation. Deaths were attributed to breast cancer if the patient had histologically or clinically confirmed breast cancer, lymph nodes or distant metastasis at the time of death or had died due to complications of breast cancer treatment.
Measured: 14 years
Breast Cancer Incidence
Information on incident breast cancer cases were obtained from the Trivandrum population-based cancer registry, hospital cancer registry of the RCC and medical records departments of other hospitals treating breast cancer patients. Collection of information was blinded to study group assignment of cases. The staging of breast cancers was done according to the UICC TNM staging system.
Measured: 14 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Jan 2006
- Primary completion31 Dec 2014
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The control group received standard of care while the intervention group received 3 rounds of screening with clinical breast examination, each 3 years apart. After the 3 rounds of screening, the participants were followed up for an additional 4 years to accrue information on breast cancer incidence and mortality, and the vital status.
- Masking
- None (open label)
- Enrolment
- 115,290 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Cancer Centre, Trivandrum, India
- Responsible party
- Sponsor
- Investigators
- Kunnambath Ramadas, MD. DNB. FAMS, PhD, Principal investigator, Regional Cancer Centre, Trivandrum, IndiaRengaswamy Sankaranarayanan, MD, Principal investigator, International Agency for Research on Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301296
- Sponsor's protocol ID
- IEC 05-05
- Acronym
- TBCS
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sankaranarayanan R, Ramadas K, Thara S, Muwonge R, Prabhakar J, Augustine P, Venugopal M, Anju G, Mathew BS. Clinical breast examination: preliminary results from a cluster randomized controlled trial in India. J Natl Cancer Inst. 2011 Oct 5;103(19):1476-80. doi: 10.1093/jnci/djr304. Epub 2011 Aug 23.
PubMed 21862730
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating of Clinical Early Detection of Breast Cancer in Trivandrum District, India
- ClinicalTrials.gov ID
- NCT05301296
- Acronym / sponsor ID
- TBCS / IEC 05-05
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115,290 participants (actual)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Collaborators
- Regional Cancer Centre, Trivandrum, India
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cluster-randomized controlled trial in Trivandrum district, Kerala, India to evaluate the effect of triennial screening for breast cancer using clinical breast examination on breast cancer mortality.
Detailed description
The study population consisted of 274 administrative regions (clusters) in Trivandrum district, Kerala, southern Indian. 133 clusters were randomly assigned to the intervention arm (3 rounds of clinical breast examination conducted 3 years apart) and were compared to the remaining 141 clusters assigned to a control arm that received standard of care. The eligibility criteria were all healthy subjects aged 30 to 69, without a personal history of breast cancer. Informed consent was signed by each participant. The intervention arm consisted of 55,843 participants and the control group consisted of 59,447 participants.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The control group received standard of care while the intervention group received 3 rounds of screening with clinical breast examination, each 3 years apart. After the 3 rounds of screening, the participants were followed up for an additional 4 years to accrue information on breast cancer incidence and mortality, and the vital status.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Standard of Care. |
| Intervention Arm | Active comparator | Diagnostic Test: Clinical examination of the breast for early detection of CancerClinical examination of the breast for early detection of Cancer. |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Residing in 274 study clusters in Trivandrum City, Kerala
Key exclusion criteria (3 listed)
- Diagnosis with breast cancer prior to study
- Bedridden subjects
- Subjects suffering from open tuberculosis or other debilitating diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical examination of the breast for early detection of CancerParticipants were invited for 3 rounds of clinical breast examination, conducted 3-years apart. Screening was conducted by health workers trained to perform clinical breast examination for early detection of cancer. Women with abnormal referable lesions underwent CBE by a trained clinician and those women with a confirmed breast lump or any other breast abnormality warranting further investigations were evaluated by triple-testing involving expert physical examination, diagnostic mammography with or without ultrasonography and fine needle aspiration cytology (FNAC) or core biopsy or excision biopsy. Those with confirmed breast cancer were referred for appropriate treatment with surgery, radiotherapy, and/or chemotherapy. | Diagnostic test | Intervention Arm |
Primary outcome
Breast Cancer Death Rate
Time frame: 14 years
Information on all deaths were collected from the municipal and district death registers, hospital medical records, death records of churches and mosques, hospital visits by the population cancer registry staff and by project health workers. Cancer cases were coded by the ICD-O 3rd edition codes and cause of death was coded using ICD-10 by the registry and project staff blinded to study group allocation. Deaths were attributed to breast cancer if the patient had histologically or clinically confirmed breast cancer, lymph nodes or distant metastasis at the time of death or had died due to complications of breast cancer treatment.
Breast Cancer Incidence
Time frame: 14 years
Information on incident breast cancer cases were obtained from the Trivandrum population-based cancer registry, hospital cancer registry of the RCC and medical records departments of other hospitals treating breast cancer patients. Collection of information was blinded to study group assignment of cases. The staging of breast cancers was done according to the UICC TNM staging system.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Results publication: PubMed 21862730Sankaranarayanan R, Ramadas K, Thara S, Muwonge R, Prabhakar J, Augustine P, Venugopal M, Anju G, Mathew BS. Clinical breast examination: preliminary results from a cluster randomized controlled trial in India. J Natl Cancer Inst. 2011 Oct 5;103(19):1476-80. doi: 10.1093/jnci/djr304. Epub 2011 Aug 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kunnambath Ramadas, MD. DNB. FAMS, PhD principal investigator
Regional Cancer Centre, Trivandrum, India
Rengaswamy Sankaranarayanan, MD principal investigator
International Agency for Research on Cancer
Questions about this trial
What is this clinical trial studying?
A study testing Clinical examination of the breast for early detection of Cancer in people with Breast Cancer, run by International Agency for Research on Cancer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Cancer Death Rate (time frame: 14 years). The study lists 2 primary outcomes in all. 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 NCT05301296, which also lists 1 linked publication.
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 29 Mar 2022.