Rapid Autopsy Protocol for Patients With Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

Official title:

Rapid ("Warm") Autopsy Protocol for Patients With Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05889546
• Other study ID #: CTO-IUSCCC-0783
• Status: Recruiting
• Start date: August 31, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Indiana University
• Contact: Tonya Hibbert
• Phone: 317-274-0930
• Email: tmarkus[@]iu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is pilot study to establish a rapid autopsy program in Small Cell Lung Cancer (SCLC) at the Indiana University Simon Comprehensive Cancer Center and outline the components necessary for tumor tissue collection.

Description:

The goal of this project to establish a rapid autopsy program in SCLC at the IUSCCC and outline the key components necessary for tumor tissue acquisition. This proposal is a collaboration between scientists, lung cancer physicians, pathologists, and the IUSCCC Translational Research Core. Tumor tissue collected will be used for protein and gene analysis and RNA, whole exome sequencing in addition to the establishment of SCLC. This research is part of a discovery project in which biological and molecular markers of SCLC will be identified.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. = 18 years old at the time of informed consent

2. Written informed consent and HIPAA authorization for release of personal health information.

3. Active SCLC diagnosis.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Procedure:
• Biospecimen Collection
Lung, liver, skin, subcutaneous metastases, and blood specimens may be collected via rapid autopsy within 10 hours of expiration.

Locations

Country	Name	City	State
United States	Indiana University Melvin and Bren Simon Comprehensive Cancer Center	Indianapolis	Indiana
United States	Sidney and Lois Eskenazi Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining the Feasibility of the Creation of a Rapid Autopsy Program at IUSCCC for SCLC through enrollment and sample collections		5 years
Primary	Utilization of Tissue to Better Understand the Complex Biology of SCLC	Utilize tissue obtained from rapid autopsies to generate novel patient derived xenograft models and tumor cell lines, in addition to RNA, whole exome and whole genome sequencing, protein extraction to better understand the complex biology of SCLC and set up an infrastructure to develop relevant clinical models that will allow the development of better therapies.	5 years