Rapid Medical Donation Programme for Breast Cancer

NCT ID: NCT02126800

Last Updated: 2014-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2019-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Metastatic Breast Cancer

Keywords

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breast cancer

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Breakthrough Breast Cancer

OTHER

Sponsor Role collaborator

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter A Barry, MB BS

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

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Royal Marsden NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Sally Bennett, RN

Role: CONTACT

Phone: +44 (0)2073528171

Email: [email protected]

Facility Contacts

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Sally Bennett, RN

Role: primary

Other Identifiers

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CCR3995

Identifier Type: -

Identifier Source: org_study_id