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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00900211
• Other study ID #: CDR0000581165
• Secondary ID: VORTEX-SA3002VOR
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2009
• Last updated: August 23, 2013
• Start date: August 2007

Study information

• Verified date: April 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Sarcoma

Intervention

Genetic:
• microarray analysis

• molecular diagnostic method

Other:
• biologic sample preservation procedure

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust	Birmingham	England
United Kingdom	Royal Orthopedic Hospital NHS Trust	Birmingham	England
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Gloucestershire Oncology Centre at Cheltenham General Hospital	Cheltenham	England
United Kingdom	Royal National Orthopaedic Hospital NHS Trust	Cheltenham	England
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow	Scotland
United Kingdom	Middlesex Hospital	London	England
United Kingdom	Christie Hospital	Manchester	England
United Kingdom	Nottingham City Hospital	Nottingham	England
United Kingdom	Glan Clwyd Hospital	Rhyl, Denbighshire	Wales
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England
United Kingdom	Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust	Shropshire	England

Sponsors (1)

Lead Sponsor	Collaborator
Christie Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased likelihood of distant metastases			No