Tissue Sample Collection From Patients With Soft Tissue Sarcoma of the Arms, Hands, Legs, or Feet Treated on Clinial Trial CRUK-VORTEX

August 23, 2013 updated by: The Christie NHS Foundation Trust

VORTEX-BIOBANK: Prospective Sample Collection for the VORTEX Randomised Radiotherapy Trial in Patients With Extremity Soft Tissue Sarcoma [VORTEX BIOBANK]

RATIONALE: Collecting and storing samples of tumor tissue from patients with soft tissue sarcoma to test in the laboratory may help the study of cancer in the future.

PURPOSE: This laboratory is collecting tissue samples from patients with soft tissue sarcoma of the arms, hands, legs, or feet treated on clinical trial CRUK-VORTEX.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine early in the course of treatment which patients treated on clinical trial CRUK-VORTEX have an increased likelihood of distant metastases so as to highlight individuals who might benefit from early adjuvant systemic therapy.

OUTLINE: This is a multicenter study.

Tumour and normal tissue samples will be taken at the time of surgery during treatment on clinical trial CRUK-VORTEXand preserved for future microarray analyses. Tissue microarrays will be produced from both tumor and normal tissues. Blood samples will be collected for future DNA analysis.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B15 2TH
        • Recruiting
        • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
        • Contact:
          • Contact Person
          • Phone Number: 44-121-472-1311
      • Birmingham, England, United Kingdom, B31 2AP
        • Recruiting
        • Royal Orthopedic Hospital NHS Trust
        • Contact:
          • Contact Person
          • Phone Number: 44-121-685-4019
      • Bristol, England, United Kingdom, BS2 8ED
        • Recruiting
        • Bristol Haematology and Oncology centre
        • Contact:
          • Contact Person
          • Phone Number: 44-117-928-2417
      • Cheltenham, England, United Kingdom, GL53 7AN
        • Recruiting
        • Gloucestershire Oncology Centre at Cheltenham General Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1242-222-222
      • Cheltenham, England, United Kingdom, GL53 7AN
        • Recruiting
        • Royal National Orthopaedic Hospital NHS Trust
        • Contact:
          • Contact Person
          • Phone Number: 44-020-8954-2300
      • London, England, United Kingdom, W1T 3AA
        • Recruiting
        • Middlesex Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-0207-380-9087
      • Manchester, England, United Kingdom, M20 4BX
      • Nottingham, England, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham City Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-115-969-1169
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Recruiting
        • Cancer Research Centre at Weston Park Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-114-226-5208
      • Shropshire, England, United Kingdom, SY10 7AG
        • Recruiting
        • Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
        • Contact:
          • Contact Person
          • Phone Number: 44-0161-446-3341
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • Recruiting
        • Beatson West of Scotland Cancer Centre
        • Contact:
          • Contact Person
          • Phone Number: 44-141-301-7000
    • Wales
      • Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
        • Recruiting
        • Glan Clwyd Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed soft tissue sarcoma
  • Receiving treatment on clinical trial CRUK-VORTEX
  • Underwent surgery to remove the tumor no more than 3 months ago

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No other major medical illness that would preclude study treatment
  • No other prior or concurrent malignancy except adequately treated nonmelanoma carcinoma of the skin or in situ carcinoma of the cervix

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy to the local site
  • No prior neoadjuvant or adjuvant chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Increased likelihood of distant metastases

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Christie NHS Foundation Trust

Investigators

  • Study Chair: Catherine West, The Christie NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000581165
  • ISRCTN76456502 (ISRCTN)
  • VORTEX-SA3002
  • VORTEX-REC-06/MRE03/3
  • EU-20795

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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