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

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ClinicalTrials.gov Identifier: NCT00900211
Recruitment Status : Unknown
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : May 12, 2009
Last Update Posted : August 26, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment
Sarcoma Genetic: microarray analysis Genetic: molecular diagnostic method Other: biologic sample preservation procedure

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 Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Official Title: VORTEX-BIOBANK: Prospective Sample Collection for the VORTEX Randomised Radiotherapy Trial in Patients With Extremity Soft Tissue Sarcoma [VORTEX BIOBANK]
Study Start Date : August 2007
Estimated Primary Completion Date : March 2012

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U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Increased likelihood of distant metastases

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900211


Locations
United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust Recruiting
Birmingham, England, United Kingdom, B15 2TH
Contact: Contact Person    44-121-472-1311      
Royal Orthopedic Hospital NHS Trust Recruiting
Birmingham, England, United Kingdom, B31 2AP
Contact: Contact Person    44-121-685-4019      
Bristol Haematology and Oncology Centre Recruiting
Bristol, England, United Kingdom, BS2 8ED
Contact: Contact Person    44-117-928-2417      
Gloucestershire Oncology Centre at Cheltenham General Hospital Recruiting
Cheltenham, England, United Kingdom, GL53 7AN
Contact: Contact Person    44-1242-222-222      
Royal National Orthopaedic Hospital NHS Trust Recruiting
Cheltenham, England, United Kingdom, GL53 7AN
Contact: Contact Person    44-020-8954-2300      
Middlesex Hospital Recruiting
London, England, United Kingdom, W1T 3AA
Contact: Contact Person    44-0207-380-9087      
Christie Hospital Recruiting
Manchester, England, United Kingdom, M20 4BX
Contact: Contact Person    44-161-446-3341    Catharine.west@manchester.ac.uk   
Nottingham City Hospital Recruiting
Nottingham, England, United Kingdom, NG5 1PB
Contact: Contact Person    44-115-969-1169      
Cancer Research Centre at Weston Park Hospital Recruiting
Sheffield, England, United Kingdom, S1O 2SJ
Contact: Contact Person    44-114-226-5208      
Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust Recruiting
Shropshire, England, United Kingdom, SY10 7AG
Contact: Contact Person    44-0161-446-3341      
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, Scotland, United Kingdom, G12 0YN
Contact: Contact Person    44-141-301-7000      
Glan Clwyd Hospital Recruiting
Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
Contact: Contact Person    44-1745-583-910      
Sponsors and Collaborators
The Christie NHS Foundation Trust
Investigators
Study Chair: Catherine West The Christie NHS Foundation Trust
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00900211     History of Changes
Other Study ID Numbers: CDR0000581165
VORTEX-SA3002
VORTEX-REC-06/MRE03/3
ISRCTN76456502
EU-20795
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: April 2008

Keywords provided by National Cancer Institute (NCI):
adult epithelioid sarcoma
recurrent adult soft tissue sarcoma
stage I adult soft tissue sarcoma
stage II adult soft tissue sarcoma
stage III adult soft tissue sarcoma
adult synovial sarcoma
adult angiosarcoma
adult extraskeletal chondrosarcoma
 adult leiomyosarcoma
adult liposarcoma
adult malignant fibrous histiocytoma
adult malignant hemangiopericytoma
adult malignant mesenchymoma
adult fibrosarcoma
adult neurofibrosarcoma

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms