Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-01-25 @ 11:10 PM
Study NCT ID:
NCT02679950
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2015-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding the Molecular and Genetic Differences Between Germ Cell Tumor at the Time of the Initial Diagnosis and at Late Relapse
Sponsor:
Nasser Hanna
Organization:
Study Overview
Official Title:
Understanding the Molecular and Genetic Differences Between GCT at the Time of the Initial Diagnosis and at Late Relapse
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: