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


N/A
16 Years
N/A
Open (Enrolling)
Both
Sarcoma

Thank you

Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Increased likelihood of distant metastases

Safety Issue:

No

Principal Investigator

Catherine West

Investigator Role:

Study Chair

Investigator Affiliation:

Christie Hospital NHS Foundation Trust

Authority:

Unspecified

Study ID:

CDR0000581165

NCT ID:

NCT00900211

Start Date:

August 2007

Completion Date:

Related Keywords:

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

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