NCT00899522

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

December 4, 2017

Status Verified

November 1, 2017

Enrollment Period

7.6 years

First QC Date

May 9, 2009

Last Update Submit

November 30, 2017

Conditions

Keywords

Fanconi anemiaunspecified adult solid tumor, protocol specificunspecified childhood solid tumor, protocol specific

Outcome Measures

Primary Outcomes (3)

  • Creation of a Fanconi Anemia Cell Repository using rare solid tumor samples from patients with Fanconi anemia

    Duration of the study

  • Study tissue samples by molecular methods, including gene microarrays

    Duration of the study

  • Development of cancer cell lines from tissue archived from patients with Fanconi anemia

    Duration of the study

Interventions

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.

biopsyPROCEDURE

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.

Eligibility Criteria

Age1 Year - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

DISEASE CHARACTERISTICS: * Confirmed Fanconi anemia * Confirmed malignant solid tumor * Biopsy of tumor tissue available PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Fanconi Anemia

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Anemia, Hypoplastic, CongenitalAnemia, AplasticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesCongenital Bone Marrow Failure SyndromesBone Marrow Failure DisordersBone Marrow DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Grover C. Bagby, MD

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emeritus

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

August 1, 2005

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

December 4, 2017

Record last verified: 2017-11

Locations