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

NCT ID: NCT00900211

Last Updated: 2013-08-26

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

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sarcoma

Keywords

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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 epithelioid sarcoma adult extraskeletal chondrosarcoma adult leiomyosarcoma adult liposarcoma adult malignant fibrous histiocytoma adult malignant hemangiopericytoma adult malignant mesenchymoma adult fibrosarcoma adult neurofibrosarcoma

Interventions

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microarray analysis

Intervention Type GENETIC

molecular diagnostic method

Intervention Type GENETIC

biologic sample preservation procedure

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Christie NHS Foundation Trust

OTHER

Sponsor Role lead

Principal Investigators

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Catherine West

Role: STUDY_CHAIR

The Christie NHS Foundation Trust

Locations

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Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, United Kingdom

Site Status RECRUITING

Royal Orthopedic Hospital NHS Trust

Birmingham, England, United Kingdom

Site Status RECRUITING

Bristol Haematology and Oncology Centre

Bristol, England, United Kingdom

Site Status RECRUITING

Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, United Kingdom

Site Status RECRUITING

Royal National Orthopaedic Hospital NHS Trust

Cheltenham, England, United Kingdom

Site Status RECRUITING

Middlesex Hospital

London, England, United Kingdom

Site Status RECRUITING

Christie Hospital

Manchester, England, United Kingdom

Site Status RECRUITING

Nottingham City Hospital

Nottingham, England, United Kingdom

Site Status RECRUITING

Cancer Research Centre at Weston Park Hospital

Sheffield, England, United Kingdom

Site Status RECRUITING

Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust

Shropshire, England, United Kingdom

Site Status RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, United Kingdom

Site Status RECRUITING

Glan Clwyd Hospital

Rhyl, Denbighshire, Wales, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Other Identifiers

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VORTEX-SA3002

Identifier Type: -

Identifier Source: secondary_id

VORTEX-REC-06/MRE03/3

Identifier Type: -

Identifier Source: secondary_id

ISRCTN76456502

Identifier Type: -

Identifier Source: secondary_id

EU-20795

Identifier Type: -

Identifier Source: secondary_id

CDR0000581165

Identifier Type: -

Identifier Source: org_study_id