SarcomaNCT00900211
Tissue Sample Collection From Patients With Soft Tissue Sarcoma of the Arms, Hands, Legs, or Feet Treated on Clinial Trial CRUK-VORTEX
An observational study of Sarcoma, run by The Christie NHS Foundation Trust at 12 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- microarray analysis, molecular diagnostic method and biologic sample preservation procedure
- How many people
- 400 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- Aug 2007to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United Kingdom12 sites, 12 recruiting
- Recruiting
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, B15 2TH
Contact Person, 44-121-472-1311
- Recruiting
Royal Orthopedic Hospital NHS Trust
Birmingham, England, B31 2AP
Contact Person, 44-121-685-4019
- Recruiting
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Contact Person, 44-117-928-2417
- Recruiting
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, GL53 7AN
Contact Person, 44-1242-222-222
- Recruiting
Royal National Orthopaedic Hospital NHS Trust
Cheltenham, England, GL53 7AN
Contact Person, 44-020-8954-2300
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN
Contact Person, 44-141-301-7000
- Recruiting
Middlesex Hospital
London, England, W1T 3AA
Contact Person, 44-0207-380-9087
- Recruiting
Christie Hospital
Manchester, England, M20 4BX
Contact Person, 44-161-446-3341, Catharine.west@manchester.ac.uk
- Recruiting
Nottingham City Hospital
Nottingham, England, NG5 1PB
Contact Person, 44-115-969-1169
- Recruiting
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, LL 18 5UJ
Contact Person, 44-1745-583-910
- Recruiting
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ
Contact Person, 44-114-226-5208
- Recruiting
Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
Shropshire, England, SY10 7AG
Contact Person, 44-0161-446-3341
About this study
Official title: VORTEX-BIOBANK: Prospective Sample Collection for the VORTEX Randomised Radiotherapy Trial in Patients With Extremity Soft Tissue Sarcoma [VORTEX BIOBANK]
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.
Read the 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.
- Conditions
- Sarcoma
- Being tested
- microarray analysis, molecular diagnostic method, biologic sample preservation procedure
- Keywords
- 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
- Medical subject headings
- Sarcoma, Sarcoma, Synovial, Hemangiosarcoma, Chondrosarcoma, Extraskeletal Myxoid, Leiomyosarcoma, Liposarcoma, Histiocytoma, Malignant Fibrous, Hemangiopericytoma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microarray analysisGenetic
molecular diagnostic methodGenetic
biologic sample preservation procedureOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased likelihood of distant metastases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startAug 2007
- Primary completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Catherine West, Study chair, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900211
- Sponsor's protocol ID
- CDR0000581165
- Other IDs
- VORTEX-SA3002, VORTEX-REC-06/MRE03/3, ISRCTN76456502, EU-20795
- Status last verified
- Apr 2008
- First submitted
- 9 May 2009
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VORTEX-BIOBANK: Prospective Sample Collection for the VORTEX Randomised Radiotherapy Trial in Patients With Extremity Soft Tissue Sarcoma [VORTEX BIOBANK]
- ClinicalTrials.gov ID
- NCT00900211
- Acronym / sponsor ID
- CDR0000581165
- Conditions
- Sarcoma
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Mar 2012 (estimated)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microarray analysis | Genetic | – |
| molecular diagnostic method | Genetic | – |
| biologic sample preservation procedure | Other | – |
Primary outcome
Increased likelihood of distant metastases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, United Kingdom
Catherine West study chair
The Christie NHS Foundation Trust
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, run by The Christie NHS Foundation Trust at 12 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased likelihood of distant metastases. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.