Correlation of Predictive Accuracy of PREDICT Version 2.2 of Indian Women With Operable Breast Cancer

NCT04985253 | Unknown

• 1 other identifier: 3055
• Study Type: observational
• Target: 2,780
• Locations: 1 country
• Sites: 1

Brief Summary

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

Operable Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Five year overall survival

  To compare the observed 5 year overall survival of operable breast cancer patients with the one predicted by PREDICT V 2.2

  5 years

Secondary Outcomes (1)

• 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)

  5 years

Study Arms (1)

Operable breast neoplasm cohort

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.

Other: prediction of overall survival using Web based PREDICTV2.0 portal

Interventions

prediction of overall survival using Web based PREDICTV2.0 portal OTHER

Predict is an online prognostication and treatment benefit tool developed in the UK, using cancer registration and survival data recorded by the Eastern Cancer Registration and Information Centre (ECRIC) for 5694 women diagnosed in East Anglia from 1999-2003. The model was validated in a second cohort of 5468 women from the West Midlands Cancer Intelligence Unit and is available online (www.predict.nhs.uk) providing 5-and 10-year survival estimates and treatment benefit predictions. Wong et al, tested the predictive accuracy of PREDICT V1.0 in the southeast Asian population. There were 67% Chinese patients while 13% were Indians. They showed concordance in observed and predicted OS in most subgroups except for women whore less than 40 years of age.

Operable breast neoplasm cohort

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participant data will be selected from all the patients underwent treatment for Breast neoplasm in Tata Memorial Hospital Mumbai-12 in year 2010-2013.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Related Publications (17)

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Related Links

• online predict tool

Study Officials

• Nita S Nair, MCH

  Professor and Surgeon (Breast Oncology)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Surgeon (Breast Surgical Oncology Services)

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: August 2, 2021
• Study Start: November 15, 2018
• Primary Completion: October 18, 2021
• Study Completion: December 31, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)