Neoplasms, Germ Cell and Embryonal Clinical Trial
Official title:
Understanding the Molecular and Genetic Differences Between GCT at the Time of the Initial Diagnosis and at Late Relapse
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.
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.
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