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

May 23, 2017 updated by: Cancer Trials Ireland

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

803

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Ireland
- - Cork, Ireland
    - Cork University Hospital
  - Cork, Ireland
    - Mercy University Hospital
  - Dublin, Ireland, 9
    - Beaumont Hospital
  - Dublin, Ireland
    - St Luke's Hospital
  - Dublin, Ireland, 7
    - Mater Misericordiae University Hospital
  - Dublin, Ireland, 4
    - St. Vincent's University Hospital
  - Dublin, Ireland, 24
    - Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
  - Dublin, Ireland, 8
    - St. James's Hospital
  - Dublin, Ireland
    - Mater Private Hospital
  - Galway, Ireland
    - University College Hospital
  - Letterkenny, Ireland
    - Letterkenny General Hospital
  - Limerick, Ireland, 0009
    - Mid-Western Cancer Centre at Mid-Western Regional Hospital
  - Waterford, Ireland
    - Waterford Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

5 different tumour types

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Melanoma
Breast
Lung
Pancreatic
Colorectal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Detection of peptide and protein markers in serum Time Frame: Ongoing	Ongoing

Secondary Outcome Measures

Outcome Measure	Time Frame
Identification of the protein/peptide involved Time Frame: Ongoing	Ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Trials Ireland

Investigators

Principal Investigator: Martin Clynes, National Institute for Cellular Biotechnology at Dublin City University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

September 9, 2009

First Submitted That Met QC Criteria