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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland
ClinicalTrials.gov Identifier:
NCT00974610
First received: September 9, 2009
Last updated: February 15, 2016
Last verified: February 2016
  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 Cancer Trials Ireland:

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
Primary Completion Date: December 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

Ages Eligible for Study:   Child, Adult, Senior
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
Cork, Ireland
Mercy University Hospital
Cork, Ireland
Beaumont Hospital
Dublin, Ireland, 9
St. Vincent's University Hospital
Dublin, Ireland, 4
Mater Misericordiae University Hospital
Dublin, Ireland, 7
St. James's Hospital
Dublin, Ireland, 8
Mater Private Hospital
Dublin, Ireland
St Luke's Hospital
Dublin, Ireland
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, Ireland, 24
University College Hospital
Galway, Ireland
Letterkenny General Hospital
Letterkenny, Ireland
Mid-Western Cancer Centre at Mid-Western Regional Hospital
Limerick, Ireland, 0009
Waterford Regional Hospital
Waterford, Ireland
Sponsors and Collaborators
Cancer Trials Ireland
Investigators
Principal Investigator: Martin Clynes National Institute for Cellular Biotechnology at Dublin City University
  More Information

Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT00974610     History of Changes
Other Study ID Numbers: 07-12 ICORG  ICORG-07-12  EU-20949 
Study First Received: September 9, 2009
Last Updated: February 15, 2016
Health Authority: Ireland: Irish Medicines Board

Keywords provided by Cancer Trials Ireland:
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

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

ClinicalTrials.gov processed this record on July 21, 2016