Clinical trial · Observational
Correlation of Predictive Accuracy of PREDICT Version 2.2 of Indian Women With Operable Breast Cancer
Correlation of Predictive Accuracy of PREDICT Version 2.2, (PREDICT V2.2) on a Retrospective Cohort of Indian Women With Operable Breast Cancer (OBC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an observational retrospective study which aims at comparing the 5-year survival estimates from "PREDICT V2.2" with observed 5-year outcome from our dataset of Indian women treated for operable breast cancer. "PREDICT V2.2" is a prognostication and treatment benefit tool developed in the UK. It is a tool available online (www.predict.nhs.uk) providing 5-and 10-year survival estimates and treatment benefit predictions, for operable breast cancer patients. We hypothesize that 5-year overall survival (OS) predictions using "PREDICT V2.2" will have reasonable accuracy and applicability to the Indian operable breast cancer patients. The predictions, if accurate, will not only reassure the patients of the benefits of the treatment being offered, which outweigh the side effects but it will also make clinician as well as patient confident about avoiding potentially toxic systemic therapies, where the benefit is too small.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Operable Breast Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| prediction of overall survival using Web based PREDICTV2.0 portal | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Operable breast neoplasm cohort
- description
- Operable breast cancer (OBC) ER +/Her2 neg or triple negative breast cancer patients diagnosed and treated at Tata Memorial Centre, Mumbai from 01 Jan 2010 to 31 Dec 2013 with a five-year follow up or events within the 5 years.
- interventionNames
- Other: prediction of overall survival using Web based PREDICTV2.0 portal
Primary outcomes (1)
- measure
- Five year overall survival
- timeFrame
- 5 years
- description
- To compare the observed 5 year overall survival of operable breast cancer patients with the one predicted by PREDICT V 2.2
Secondary outcomes (1)
- measure
- To compare the observed 5 year overall survival of operable breast cancer patients with the one predicted by PREDICT V2.0V 2.2 for subgroups like age at diagnosis, stage of disease, tumour grade and molecular class (ER/PR positive or TNBC)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * OBC patients treated at TMH * ER +/Her2 neg or TNBC * We will include2780 women wherein events / 5-year follow up is available. We propose to have a blinded member of the DMG identify such cases and provide to the study team. Exclusion Criteria: . • Missing variables egpT size, chemotherapy details * Lost to follow up * Her2 overexpression positive or Equivocal on IHC. (This is being excluded to avoid the bias of incomplete treatment as a large number of patients treated in 2010-2013 may not have received Her2 targeted treatment in our setting)
References
Publications (17)
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