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

Sponsor

The Christie NHS Foundation Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT00900211

Collaborator

(none)

400

Enrollment

Locations

33.3

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Genetic: microarray analysis Genetic: molecular diagnostic method Other: biologic sample preservation procedure

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Official Title:

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

Study Start Date :

Aug 1, 2007

Anticipated Primary Completion Date :

Mar 1, 2012

Outcome Measures

Primary Outcome Measures

Increased likelihood of distant metastases []

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust	Birmingham	England	United Kingdom	B15 2TH
2	Royal Orthopedic Hospital NHS Trust	Birmingham	England	United Kingdom	B31 2AP
3	Bristol Haematology and Oncology Centre	Bristol	England	United Kingdom	BS2 8ED
4	Gloucestershire Oncology Centre at Cheltenham General Hospital	Cheltenham	England	United Kingdom	GL53 7AN
5	Royal National Orthopaedic Hospital NHS Trust	Cheltenham	England	United Kingdom	GL53 7AN
6	Middlesex Hospital	London	England	United Kingdom	W1T 3AA
7	Christie Hospital	Manchester	England	United Kingdom	M20 4BX
8	Nottingham City Hospital	Nottingham	England	United Kingdom	NG5 1PB
9	Cancer Research Centre at Weston Park Hospital	Sheffield	England	United Kingdom	S1O 2SJ
10	Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust	Shropshire	England	United Kingdom	SY10 7AG
11	Beatson West of Scotland Cancer Centre	Glasgow	Scotland	United Kingdom	G12 0YN
12	Glan Clwyd Hospital	Rhyl, Denbighshire	Wales	United Kingdom	LL 18 5UJ