Rapid Autopsy Protocol for Patients with Small Cell Lung Cancer

Recruiting

• Conditions: Small Cell Lung Cancer
• Interventions: Procedure: Biospecimen Collection

• Registration Number: NCT05889546
• Lead Sponsor: Indiana University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-08-31
• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-06-02
• Study First Posted: 2023-06-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active SCLC Diagnosis	Biospecimen Collection	-

Primary Outcome Measures

Name	Time	Method
Determining the Feasibility of the Creation of a Rapid Autopsy Program at IUSCCC for SCLC through enrollment and sample collections	5 years
Utilization of Tissue to Better Understand the Complex Biology of SCLC	5 years	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.

Trial Locations

Locations (3)

Roudebush VA Medical Center; 🇺🇸 Indianapolis, Indiana, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Sidney and Lois Eskenazi Hospital; 🇺🇸 Indianapolis, Indiana, United States