NCT00899132

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is evaluating a tumor marker for testicular cancer, skin cancer, small intestine cancer, and pancreatic cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2.3 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
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

5.6 years

First QC Date

May 9, 2009

Last Update Submit

September 28, 2015

Conditions

Non-melanomatous Skin CancerPancreatic CancerSmall Intestine CancerTesticular Germ Cell Tumor

Keywords

skin cancersmall intestine cancerpancreatic cancermalignant testicular germ cell tumortesticular teratoma

Outcome Measures

Primary Outcomes (2)

  • Identification of TAB3 transcript/protein as a molecular marker of cancer

    end of study

  • Characterization of TAB3 and its signaling networks that are involved in tumorigenesis

    end of study

Interventions

in situ hybridizationGENETIC

Tumor tissue samples from paraffin-embedded tissue blocks are analyzed for TAB3 transcript and protein expression using in situ hybridization and immunostaining with TAB3 cRNA probe and antibody. Antibodies against the proteins involved in the NFkB signaling pathway (e.g., p65, TAK1, MyD88, and Akt) are used in the immunostaining assays.

protein expression analysisGENETIC

Tumor tissue samples from paraffin-embedded tissue blocks are analyzed for TAB3 transcript and protein expression using in situ hybridization and immunostaining with TAB3 cRNA probe and antibody. Antibodies against the proteins involved in the NFkB signaling pathway (e.g., p65, TAK1, MyD88, and Akt) are used in the immunostaining assays.

immunologic techniqueOTHER

Tumor tissue samples from paraffin-embedded tissue blocks are analyzed for TAB3 transcript and protein expression using in situ hybridization and immunostaining with TAB3 cRNA probe and antibody. Antibodies against the proteins involved in the NFkB signaling pathway (e.g., p65, TAK1, MyD88, and Akt) are used in the immunostaining assays.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care center

DISEASE CHARACTERISTICS: * Paraffin tissue blocks from surgical pathology cancer cases, specifically testicular, skin, small intestine, and pancreatic cancer, 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)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue samples from paraffin-embedded tissue blocks.

MeSH Terms

Conditions

Pancreatic NeoplasmsTesticular Germ Cell TumorSkin NeoplasmsTesticular NeoplasmsTeratoma, Testicular

Interventions

In Situ HybridizationImmunologic Techniques

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesTesticular DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Staining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesNucleic Acid HybridizationGenetic Techniques

Study Officials

  • Ge Jin, PhD

    Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

February 1, 2007

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations

US(1)