Ignite Creation Date:
2024-05-06 @ 8:08 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02679950
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2015-11-09
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:
Indiana University
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 GCTs 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 GCTs with a component of yolk sac tumor at the time of diagnosis and GCTs 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 GCTs with a component of yolk sac tumor at the time of diagnosis and GCTs 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:
None
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?:
None