Tissue Sample Collection From Patients With Fanconi Anemia

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00899522

First Posted: May 12, 2009

Last Update Posted: May 19, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

OHSU Knight Cancer Institute

Purpose

RATIONALE: Collecting and storing samples of tumor tissue from patients with Fanconi anemia to test in the laboratory may help the study of cancer in the future.

PURPOSE: This laboratory study is collecting and storing tumor tissue samples from patients with Fanconi anemia.

Condition	Intervention
Fanconi Anemia Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific	Other: biologic sample preservation procedure Procedure: biopsy


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Retrospective
Official Title:	Fanconi Anemia Cancer Cell Repository

Resource links provided by NLM:

Genetics Home Reference related topics: Fanconi anemia

MedlinePlus related topics: Anemia

Genetic and Rare Diseases Information Center resources: Fanconi Anemia Congenital Aplastic Anemia Fanconi Syndrome Nephropathic Cystinosis Primary Fanconi Syndrome

U.S. FDA Resources

Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:

Creation of a Fanconi Anemia Cell Repository using rare solid tumor samples from patients with Fanconi anemia [ Time Frame: Duration of the study ]
Study tissue samples by molecular methods, including gene microarrays [ Time Frame: Duration of the study ]
Development of cancer cell lines from tissue archived from patients with Fanconi anemia [ Time Frame: Duration of the study ]


Enrollment:	8
Study Start Date:	August 2005
Study Completion Date:	May 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Once the pathologist has taken the material needed to establish diagnosis of cancer, the anonymized snap-frozen and fresh samples will be either shipped to our laboratory for analysis or will be picked up by a member of the principal investigator's lab team. Samples will be stored indefinitely.

Once the pathologist has taken the material needed to establish diagnosis of cancer, 1-10 grams of the remaining tissue should be placed in phosphate buffered saline and shipped to the Bagby Lab.

Detailed Description:

OBJECTIVES:

Acquire rare solid tumor samples from patients with Fanconi anemia in order to create a Fanconi Anemia Cell Repository at the Oregon Health and Science University Cancer Institute.
Study repository tissue using a variety of molecular methods, including gene microarrays.
Develop cancer cell lines that are publicly available from tissue archived from patients with Fanconi anemia.

OUTLINE: Tumor biopsies are collected from patients with Fanconi anemia and archived for future molecular studies, cell line generation, and general usage by the research community at large. Medical information about the patient's cancer is also archived.

PROJECTED ACCRUAL: Not specified.

Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	1 Year to 55 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

To recruit participants into this project, an announcement will be posted on the Fanconi Anemia Research Fund website (http://www.fanconi.org/) after IRB approval is obtained.

Criteria

DISEASE CHARACTERISTICS:

Confirmed Fanconi anemia
Confirmed malignant solid tumor
Biopsy of tumor tissue available

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899522

Locations


United States, Oregon
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098

Sponsors and Collaborators

OHSU Knight Cancer Institute

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Grover C. Bagby, MD	OHSU Knight Cancer Institute

More Information


Responsible Party:	OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:	NCT00899522 History of Changes
Other Study ID Numbers:	CDR0000445453 P30CA069533 ( U.S. NIH Grant/Contract ) OHSU-HEM-03022-LX OHSU-IRB00001100 OSHU-CR00003822
First Submitted:	May 9, 2009
First Posted:	May 12, 2009
Last Update Posted:	May 19, 2014
Last Verified:	May 2014

Keywords provided by OHSU Knight Cancer Institute:


Fanconi anemia unspecified adult solid tumor, protocol specific unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:


Anemia Fanconi Anemia Anemia, Hypoplastic, Congenital Anemia, Aplastic Neoplasms Fanconi Syndrome Hematologic Diseases Bone Marrow Diseases	Genetic Diseases, Inborn DNA Repair-Deficiency Disorders Metabolic Diseases Renal Tubular Transport, Inborn Errors Kidney Diseases Urologic Diseases Metabolism, Inborn Errors

To Top