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Study of Blood Samples From Patients With Malignant Melanoma, Metastatic Breast Cancer, Advanced Lung Cancer, Pancreatic Cancer, or Colorectal Cancer. ICORG 07-12

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by ICORG- All Ireland Cooperative Oncology Research Group
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00974610
First received: September 9, 2009
Last updated: August 11, 2014
Last verified: January 2014
  Purpose

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.


Condition
Breast Cancer
Colorectal Cancer
Lung Cancer
Melanoma (Skin)
Pancreatic Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Collaborative Project on Potential Serum Markers for Malignant Melanoma, Metastatic Breast, Advanced Lung Pancreatic Carcinoma and Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:

Primary Outcome Measures:
  • Detection of peptide and protein markers in serum [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identification of the protein/peptide involved [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: August 2008
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast
Lung
Melanoma
Pancreatic
Colorectal

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

5 different tumour types

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974610

Locations
Ireland
Cork University Hospital Recruiting
Cork, Ireland
Contact: Contact Person    353-21-492-1301      
Mercy University Hospital Recruiting
Cork, Ireland
Contact: Contact Person    021-4271971      
Beaumont Hospital Recruiting
Dublin, Ireland, 9
Contact: Contact Person    353-21-492-1301      
St. Vincent's University Hospital Recruiting
Dublin, Ireland, 4
Contact: Contact Person    353-1-209-4895      
Mater Misericordiae University Hospital Recruiting
Dublin, Ireland, 7
Contact: Contact Person    353-1-858-569      
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital Recruiting
Dublin, Ireland, 24
Contact: Contact Person    353-1-414-2012      
St Luke's Hospital Active, not recruiting
Dublin, Ireland
St. James's Hospital Recruiting
Dublin, Ireland, 8
Contact: Contact Person    353-1-410-3545      
Mater Private Hospital Recruiting
Dublin, Ireland
Contact: Contact Person    01 885 8888      
University College Hospital Recruiting
Galway, Ireland
Contact: Contact Person    353-91-544-805      
Letterkenny General Hospital Recruiting
Letterkenny, Ireland
Contact: Contact Person       consumer.serviceslgh@hse.ie   
Mid-Western Cancer Centre at Mid-Western Regional Hospital Recruiting
Limerick, Ireland, 0009
Contact: Contact Person    353-61-482-542      
Waterford Regional Hospital Recruiting
Waterford, Ireland
Contact: Contact Person    353-51-842-562      
Sponsors and Collaborators
ICORG- All Ireland Cooperative Oncology Research Group
Investigators
Principal Investigator: Martin Clynes National Institute for Cellular Biotechnology at Dublin City University
  More Information

Additional Information:
No publications provided

Responsible Party: ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier: NCT00974610     History of Changes
Other Study ID Numbers: CDR0000644159, ICORG-07-12, EU-20949
Study First Received: September 9, 2009
Last Updated: August 11, 2014
Health Authority: Ireland: Irish Medicines Board

Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
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
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Lung Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Endocrine Gland Neoplasms
Gastrointestinal Neoplasms
Intestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Respiratory Tract Neoplasms
Thoracic Neoplasms
Melanoma
Breast Diseases
Colonic Diseases
Digestive System Diseases
Endocrine System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Lung Diseases
Nevi and Melanomas
Pancreatic Diseases
Rectal Diseases
Respiratory Tract Diseases
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014