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

NCT02679950 | Completed

• 1 other identifier: IUSCC-0540
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Neoplasms, Germ Cell and Embryonal

Keywords

Next generation genome sequencing; Late relapse; Genetic profiles

Outcome Measures

Primary Outcomes (1)

• Compare genomic profiles of curable germ cell tumors with non curable germ cell tumors

  Collection of tissue and blood samples from 6 patients for genomic testing

  1 year

Study Arms (2)

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

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

Interventions

Next generation genome sequencing GENETIC

DNA will be extracted from each sample and assayed.

Initial diagnosis; Late relapse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Nasser Hanna: lead

Study Sites (2)

Indiana University Health Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue Blood samples

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Study Officials

• Nasser Hanna, MD

  Indiana University School of Medicine, Indiana University Simon Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: February 11, 2016
• Study Start: November 20, 2015
• Primary Completion: April 25, 2017
• Study Completion: April 25, 2017
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

US (2)