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

The Christie NHS Foundation Trust

Status: Unknown

Conditions: Sarcoma

Treatments: Genetic: molecular diagnostic method; Genetic: microarray analysis; Other: biologic sample preservation procedure

Study type: Observational

Funder types: Other

Identifiers

NCT00900211

EU-20795

CDR0000581165

VORTEX-REC-06/MRE03/3

VORTEX-SA3002

ISRCTN76456502 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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