Breast CancerNCT00974610
Study of Blood Samples From Patients With Malignant Melanoma, Metastatic Breast Cancer, Advanced Lung Cancer, Pancreatic Cancer, or Colorectal Cancer.
An observational study of Breast Cancer and Colorectal Cancer, run by Cancer Trials Ireland at 13 sites in Ireland.
Trial summary
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in peptides and proteins and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Lung Cancer
- How many people
- 803 participants
- Where
- 13 sitesIreland
- Study dates
- Aug 2008to Jan 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 5 different tumour types
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following advanced metastatic malignancies:
- Malignant melanoma
- Lung cancer
- Breast cancer
- Pancreatic carcinoma
- Colorectal cancer
- Advanced and/or metastatic disease
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Ireland13 sites
Cork University Hospital
Cork
Mercy University Hospital
Cork
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, 24
St. Vincent's University Hospital
Dublin, 4
Mater Misericordiae University Hospital
Dublin, 7
St. James's Hospital
Dublin, 8
Beaumont Hospital
Dublin, 9
Mater Private Hospital
Dublin
St Luke's Hospital
Dublin
University College Hospital
Galway
Letterkenny General Hospital
Letterkenny
Mid-Western Cancer Centre at Mid-Western Regional Hospital
Limerick, 0009
Waterford Regional Hospital
Waterford
About this study
Official title: Collaborative Project on Potential Serum Markers for Malignant Melanoma, Metastatic Breast, Advanced Lung Pancreatic Carcinoma and Colorectal Cancer
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in peptides and proteins and identify biomarkers related to cancer.
PURPOSE: This research study is looking at blood samples from patients with malignant melanoma, metastatic breast cancer, advanced lung cancer, pancreatic cancer, or colorectal cancer.
Read the detailed description
OBJECTIVES:
Primary
- To assess which potential peptide and protein markers produced by human melanoma, lung, breast, pancreatic, and colorectal cell lines may be detectable in serum of patients from these five disease groups.
Secondary
- To conduct further extensive investigation with respect to identification of the protein/peptide involved, determination of specificity for each cancer, and development of more sensitive assays to look for such markers in a wider population of patients, including those undergoing therapy.
OUTLINE: This is a multicenter study.
Blood samples are collected before surgical intervention or treatment to assess peptide and protein markers.
- Keywords
- stage IV melanoma, recurrent melanoma, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, stage IV breast cancer, recurrent breast cancer, male breast cancer, stage III pancreatic cancer, stage IV pancreatic cancer, recurrent pancreatic cancer, stage IV colon cancer, recurrent colon cancer, stage IV rectal cancer, recurrent rectal cancer
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Melanoma, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast | Not described | |
| Lung | Not described | |
| Melanoma | Not described | |
| Pancreatic | Not described | |
| Colorectal | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of peptide and protein markers in serum
Measured: Ongoing
Secondary outcomes (1)
Identification of the protein/peptide involved
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startAug 2008
- Primary completionDec 2015
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Martin Clynes, Principal investigator, National Institute for Cellular Biotechnology at Dublin City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974610
- Sponsor's protocol ID
- CTRIAL-IE (ICORG) 07-12
- Other IDs
- CTRIAL-IE (ICORG) 07-12, EU-20949
- Status last verified
- May 2017
- First submitted
- 9 Sep 2009
- Last updated
- 24 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Project on Potential Serum Markers for Malignant Melanoma, Metastatic Breast, Advanced Lung Pancreatic Carcinoma and Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00974610
- Acronym / sponsor ID
- CTRIAL-IE (ICORG) 07-12
- Keywords
- stage IV melanoma, recurrent melanoma, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, stage IV breast cancer, recurrent breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Aug 2008
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 10 Sep 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: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in peptides and proteins and identify biomarkers related to cancer.
PURPOSE: This research study is looking at blood samples from patients with malignant melanoma, metastatic breast cancer, advanced lung cancer, pancreatic cancer, or colorectal cancer.
Detailed description
OBJECTIVES:
Primary
- To assess which potential peptide and protein markers produced by human melanoma, lung, breast, pancreatic, and colorectal cell lines may be detectable in serum of patients from these five disease groups.
Secondary
- To conduct further extensive investigation with respect to identification of the protein/peptide involved, determination of specificity for each cancer, and development of more sensitive assays to look for such markers in a wider population of patients, including those undergoing therapy.
OUTLINE: This is a multicenter study.
Blood samples are collected before surgical intervention or treatment to assess peptide and protein markers.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Breast | – | – |
| Lung | – | – |
| Melanoma | – | – |
| Pancreatic | – | – |
| Colorectal | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 5 different tumour types
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of peptide and protein markers in serum
Time frame: Ongoing
1 secondary outcome
Identification of the protein/peptide involved
Time frame: Ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
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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.
Martin Clynes principal investigator
National Institute for Cellular Biotechnology at Dublin City University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Colorectal Cancer, run by Cancer Trials Ireland at 13 sites in Ireland.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of peptide and protein markers in serum (time frame: Ongoing). 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 24 May 2017.