Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Understanding the Molecular and Genetic Differences Between Germ Cell Tumor at the Time of the Initial Diagnosis and at Late Relapse

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.
 
ClinicalTrials.gov Identifier: NCT02679950
Recruitment Status : Completed
First Posted : February 11, 2016
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Nasser Hanna, Indiana University

Brief Summary:

The current proposal is a pilot study. The Investigators plan to use next generation genome sequencing (NGGS) to define the molecular and genetic profiles of 3 cases of germ cell tumor (GCT) (with a component of yolk sac tumor) at the time of the initial diagnosis and 3 cases of late relapse GCT's, which are characterized by yolk sac tumor (and AFP secreting) predominant disease.

Investigators seek to demonstrate the feasibility of obtaining tissue biopsies (either archived or new biopsy) and utilization of NGGS in studying the molecular and genetic relationships between GCT's (with a component of yolk sac tumor) at the time of diagnosis and GCT's at the time of late relapse. This study will also provide preliminary information on genetic alterations, which may be a hypothesis for generating another study.


Condition or disease Intervention/treatment
Neoplasms, Germ Cell and Embryonal Genetic: Next generation genome sequencing

Detailed Description:

This study will examine two cohorts:

  1. The initial diagnosis only cohort will include 3 patients with GCT who meet the inclusion criteria and have adequate tissue samples available in storage at the Pathology Department. One prospective blood and one tissue sample will be collected from each patient in this cohort. Tissue samples will come from the orchiectomy or virgin retro-peritoneal lymph node dissection (RPLND) that was done at initial diagnosis.
  2. The late relapse cohort will include 3 patients with late relapse GCT who meet the inclusion criteria and have adequate tissue samples available in storage at the Pathology Department. One prospective blood and two tissue samples will be collected from each patient in this cohort. Tissue samples will come from the orchiectomy or virgin RPLND that was done at initial diagnosis and the other will come from the site of late relapse.

Patients in this cohort will have biopsies at the site of late relapse as part of their routine cancer treatment. No biopsies will be performed specifically for the purposes of this study. Tissue from the site of late relapse will also be requested from the Pathology Department.

One tube of blood will be collected from each subject during a routine clinical visit at baseline when a blood draw is already being done.

In summary, a total of 15 samples will be evaluated on this study. Consent for the use of tissue and blood collected for the purposes of this study will be obtained prior to any study procedures. Subjects who do not have adequate tissue samples available will be replaced.

Layout table for study information
Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Understanding the Molecular and Genetic Differences Between GCT at the Time of the Initial Diagnosis and at Late Relapse
Actual Study Start Date : November 20, 2015
Actual Primary Completion Date : April 25, 2017
Actual Study Completion Date : April 25, 2017

Group/Cohort Intervention/treatment
Initial diagnosis
The initial diagnosis only cohort will include 3 patients with germ cell tumor (GCT) who meet the inclusion criteria and have adequate tissue samples available in storage at the Pathology Department. One prospective blood and one tissue sample will be collected from each patient in this cohort. Tissue samples will come from the orchiectomy or virgin retro-peritoneal lymph node dissection (RPLND) that was done at initial diagnosis.
Genetic: Next generation genome sequencing
DNA will be extracted from each sample and assayed.

Late relapse

The late relapse cohort will include 3 patients with late relapse germ cell tumor (GCT) who meet the inclusion criteria and have adequate tissue samples available in storage at the Pathology Department. One prospective blood and two tissue samples will be collected from each patient in this cohort. Tissue samples will come from the orchiectomy or virgin retro-peritoneal lymph node dissection (RPLND) that was done at initial diagnosis and the other will come from the site of late relapse.

Patients in this cohort will have biopsies at the site of late relapse as part of their routine cancer treatment. No biopsies will be performed specifically for the purposes of this study. Tissue from the site of late relapse will also be requested from the Pathology Department.

Genetic: Next generation genome sequencing
DNA will be extracted from each sample and assayed.




Primary Outcome Measures :
  1. Compare genomic profiles of curable germ cell tumors with non curable germ cell tumors [ Time Frame: 1 year ]
    Collection of tissue and blood samples from 6 patients for genomic testing


Biospecimen Retention:   Samples With DNA
Tumor tissue Blood samples


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with germ cell tumor (GCT) (with a component of yolk sac tumor) at the time of the initial diagnosis or a late relapsed GCT.
Criteria

Eligible patients will have:

  1. Germ cell tumor (GCT) (with a component of yolk sac tumor) at the time of the initial diagnosis or a late relapsed GCT (for the purposes of this study, late relapse will be defined as relapse > 2 years from the initial treatment of GCT).
  2. Adequate tumor specimens available from the initial orchiectomy specimen or virgin retro-peritoneal lymph node dissection (RPLND).
  3. Adequate tumor specimens available from any site of recurrent disease for patients accrued in the "late relapse" cohort.
  4. Tumor specimens collected prior to start of chemotherapy in the "late relapse" cohort.
  5. Age > 18 years
  6. Willing to provide informed consent

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): NCT02679950


Locations
Layout table for location information
United States, Indiana
Indiana University Health Hospital
Indianapolis, Indiana, United States, 46202
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Nasser Hanna
Investigators
Layout table for investigator information
Principal Investigator: Nasser Hanna, MD Indiana University School of Medicine, Indiana University Simon Cancer Center
Layout table for additonal information
Responsible Party: Nasser Hanna, Associate Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT02679950    
Other Study ID Numbers: IUSCC-0540
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Keywords provided by Nasser Hanna, Indiana University:
Next generation genome sequencing
Late relapse
Genetic profiles
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Germ Cell and Embryonal
Recurrence
Disease Attributes
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms