Breast Cancer Registry to collect epidemiological data, treatment patterns & outcomes of breast cancer patients in India

Recruiting

• Conditions: Breast Cancer Patients

• Registration Number: CTRI/2014/09/004972
• Lead Sponsor: Dr Vinod Raina

Brief Summary

Breast cancer is the commonest cancer in women in urban India and accounts for about 25% to 33% of all cancers in women. Most of the risk factors and other features of breast cancer are usually identical round the world. However, each country has unique characteristics of cancer. e.g. about 50-55% of breast cancer cases were detected at late (III and IV) stage; in contrast to the 15% in US. Estrogen (ER) and HER2 are currently used in routine pathological assessment of breast cancer due to their predictive and prognostic role in management of breast cancer. Present Indian data is limited to few centers involved in population based cancer registry or of individual centers only. This may not reflect actual national incidence and frequencies of above mentioned aspects of breast cancer.

**Objective**

- To register new Breast Cancer patients and record their demographic, clinical and pathological features.

- To collate information on clinical course of the disease, treatment and after therapy follow-up.

- To collate the epidemiological data with emphasis on the biological markers in breast cancer

- To explore possibility to launch a national registry based on initial experience.

The data of breast cancer patient will be collected prospectively in new patients with the help of web based software or patient registry tool (PRT). Decisions related to treatment would be the choice of the treating doctor. Within a week of assessment/visit to OPD, the patient’s data from medical records will be entered using PRT. The registry will record the data available on demographics, relevant history, treatment given, recurrence and progression of disease, last follow up & death.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-25
• Last Update Posted: 2014-03-09

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

•Newly diagnosed early breast cancer patients •Newly diagnosed metastatic breast cancer patients •Patient diagnosed as early breast cancer progressed to mBC and not treated for metastatic disease( i.e. first line mBC patients).

Exclusion Criteria

•2nd line metastatic breast cancer patients i.e. mBC patient treated earlier for their metastatic disease.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportions of new Breast Cancer patients	12 months
Proportions of patients with recurrence, progression of disease, survival and death	12 months

Secondary Outcome Measures

Name	Time	Method
Proportions of patients with recurrence, progression of disease, survival and death	12 months

Trial Locations

Locations (9)

Birla Cancer Center; 🇮🇳 Jaipur, RAJASTHAN, India

BLK Super Speciality Hospital; 🇮🇳 Delhi, DELHI, India

Fortis Hospital, Mulund; 🇮🇳 Mumbai, MAHARASHTRA, India

Fortis Memorial Research Institute; 🇮🇳 Gurgaon, HARYANA, India

INDRAPRASTHA APOLLO HOSPITALS; 🇮🇳 Delhi, DELHI, India

P.D Hinduja National Hospital and Medical Research; 🇮🇳 Mumbai, MAHARASHTRA, India

Prateeksha Oncology Clinic; 🇮🇳 Kozhikode, KERALA, India

Rajiv Gandhi Cancer Institute & Research Centre; 🇮🇳 West, DELHI, India

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Birla Cancer Center

🇮🇳Jaipur, RAJASTHAN, India

Dr Hemant Malhotra

Principal investigator

drmalhotrahemant@gmail.com