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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
Recruitment status was: Recruiting
Sponsor:
The Christie NHS Foundation Trust
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00900211
First received: May 9, 2009
Last updated: August 23, 2013
Last verified: April 2008
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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
Malignant Peripheral Nerve Sheath Tumor
Neurofibrosarcoma
Liposarcoma
Chondrosarcoma
Undifferentiated Pleomorphic Sarcoma
Leiomyosarcoma
Epithelioid Sarcoma
Synovial 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) |
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| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900211
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | May 9, 2009 |
| Last Updated: | August 23, 2013 |
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 |
ClinicalTrials.gov processed this record on July 26, 2017