NCT00900211

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Last Updated

August 26, 2013

Status Verified

April 1, 2008

Enrollment Period

4.6 years

First QC Date

May 9, 2009

Last Update Submit

August 23, 2013

Conditions

Sarcoma

Keywords

recurrent adult soft tissue sarcomastage I adult soft tissue sarcomastage II adult soft tissue sarcomastage III adult soft tissue sarcomaadult synovial sarcomaadult angiosarcomaadult epithelioid sarcomaadult extraskeletal chondrosarcomaadult leiomyosarcomaadult liposarcomaadult malignant fibrous histiocytomaadult malignant hemangiopericytomaadult malignant mesenchymomaadult fibrosarcomaadult neurofibrosarcoma

Outcome Measures

Primary Outcomes (1)

  • Increased likelihood of distant metastases

Interventions

microarray analysisGENETIC
molecular diagnostic methodGENETIC
biologic sample preservation procedureOTHER

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (12)

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2TH, United Kingdom

RECRUITING

Royal Orthopedic Hospital NHS Trust

Birmingham, England, B31 2AP, United Kingdom

RECRUITING

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

RECRUITING

Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

RECRUITING

Royal National Orthopaedic Hospital NHS Trust

Cheltenham, England, GL53 7AN, United Kingdom

RECRUITING

Middlesex Hospital

London, England, W1T 3AA, United Kingdom

RECRUITING

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

RECRUITING

Nottingham City Hospital

Nottingham, England, NG5 1PB, United Kingdom

RECRUITING

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

RECRUITING

Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust

Shropshire, England, SY10 7AG, United Kingdom

RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

RECRUITING

Glan Clwyd Hospital

Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

SarcomaSarcoma, SynovialHemangiosarcomaChondrosarcoma, Extraskeletal MyxoidLeiomyosarcomaLiposarcomaHistiocytoma, Malignant FibrousHemangiopericytoma, MalignantMalignant mesenchymal tumorFibrosarcomaNeurofibrosarcoma

Interventions

Microarray AnalysisMolecular Diagnostic Techniques

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Connective TissueNeoplasms, Vascular TissueNeoplasms, Muscle TissueNeoplasms, Adipose TissueHistiocytomaNeoplasms, Fibrous TissueNeurofibromaNerve Sheath NeoplasmsNeoplasms, Nerve TissuePeripheral Nervous System NeoplasmsNervous System NeoplasmsNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Microchip Analytical ProceduresInvestigative TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisGenetic Techniques

Study Officials

  • Catherine West

    The Christie NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

August 1, 2007

Primary Completion

March 1, 2012

Last Updated

August 26, 2013

Record last verified: 2008-04

Locations

GB(12)