Rapid Medical Donation Programme for Breast Cancer

NCT02126800 | Unknown DMC

• 1 other identifier: CCR3995
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of breast cancer has traditionally been based on the primary tumour's features in the breast. Only recently, when cancer returns at other sites, has there been an attempt to biopsy the metastatic disease and change treatments accordingly. A 'repeat biopsy' can be technically difficult, painful and, when possible, only represents a small sample of one of many metastases. Even when one deposit responds to a new treatment, a neighbouring one may continue to grow. There is an urgent need to characterise all deposits, particularly the lethal ones which progress despite all treatments. This study will enable the comprehensive analysis of the metastatic process and the evolution of the breast cancer through the course of its treatment. Patients who have consented during life to donate their tissues for molecular analysis will provide the means for such an analysis. Main aims:

• To comprehensively and systematically examine metastatic breast cancer by its detailed exploratory molecular characterization to elucidate the possible inter- and intratumoural heterogeneity between the primary tumour and the majority of metastatic sites.
• To map the natural history of the metastatic breast cancer process

Conditions

Metastatic Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

• The acquisition of tumour tissue from multiple metastatic sites.

  Within 6 hours from the time of death.

Eligibility Criteria

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

Study Population

Patients with proven metastatic breast cancer

You may qualify if:

• Patients who have completed active treatment (or trials) for metastatic breast cancer.
• Patients referred to either community or the hospital-based palliative care unit from Royal Marsden National Health Service Foundation Trust.

You may not qualify if:

• Lack of capacity / inability to give informed consent.
• Diagnosis of alternative cancer within the last 5 years other than resected basal cell skin cancer or cervical intraepithelial neoplasia.
• Patients known to be HIV, Hepatitis B virus or Hepatitis C virus positive on serology .
• Spongiform encephalopathy (known or suspected CJD) .
• Eligibility for or current participation in a clinical trial (excluding palliative care trials)

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Breakthrough Breast Cancer: collaborator
• Institute of Cancer Research, United Kingdom: collaborator

Study Sites (1)

Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Metastatic breast cancer

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peter A Barry, MB BS

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sally Bennett, RN

CONTACT

+44 (0)2073528171; LEGACY-BC@icr.ac.uk

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 30, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: March 1, 2019
• Last Updated: April 30, 2014

Record last verified: 2014-04

Locations

GB (1)