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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00900211

First Posted: May 12, 2009

Last Update Posted: August 26, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

National Cancer Institute (NCI)

Purpose

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	Intervention
Sarcoma	Genetic: microarray analysis Genetic: molecular diagnostic method Other: biologic sample preservation procedure


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

Resource links provided by NLM:

MedlinePlus related topics: Soft Tissue Sarcoma

Genetic and Rare Diseases Information Center resources: Soft Tissue Sarcoma Synovial Sarcoma Leiomyosarcoma Malignant Peripheral Nerve Sheath Tumor Neurofibrosarcoma Liposarcoma Chondrosarcoma Undifferentiated Pleomorphic Sarcoma Epithelioid Sarcoma Hemangiopericytoma Fibrosarcoma Malignant Mesenchymoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Increased likelihood of distant metastases


Estimated Enrollment:	400
Study Start Date:	August 2007
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

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.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

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


ClinicalTrials.gov Identifier:	NCT00900211 History of Changes
Other Study ID Numbers:	CDR0000581165 VORTEX-SA3002 VORTEX-REC-06/MRE03/3 ISRCTN76456502 EU-20795
First Submitted:	May 9, 2009
First Posted:	May 12, 2009
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

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