Clinical trial NCT00974610: Study of Blood Samples From Patients With Malignant Melanoma, Metastatic Breast Cancer, Advanced Lung Cancer, Pancreatic Cancer, or Colorectal Cancer.
Official title: Collaborative Project on Potential Serum Markers for Malignant Melanoma, Metastatic Breast, Advanced Lung Pancreatic Carcinoma and Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Colorectal Cancer
Lung Cancer
Melanoma (Skin)
Pancreatic Cancer
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
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2009-09-10
Enrollment: 803
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 5 different tumour types

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Detection of peptide and protein markers in serum
timeFrame: Ongoing
Secondary outcomes:
measure: Identification of the protein/peptide involved
timeFrame: Ongoing
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
city: Cork
country: Ireland
facility: Mercy University Hospital
city: Dublin
country: Ireland
facility: Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
city: Dublin
country: Ireland
facility: St. Vincent's University Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Dublin
country: Ireland
facility: St. James's Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: Mater Private Hospital
city: Dublin
country: Ireland
facility: St Luke's Hospital
city: Galway
country: Ireland
facility: University College Hospital
city: Letterkenny
country: Ireland
facility: Letterkenny General Hospital
city: Limerick
country: Ireland
facility: Mid-Western Cancer Centre at Mid-Western Regional Hospital
city: Waterford
country: Ireland
facility: Waterford Regional Hospital
Study officials:
affiliation: National Institute for Cellular Biotechnology at Dublin City University
name: Martin Clynes
role: PRINCIPAL_INVESTIGATOR
References: