Rapid Autopsy Protocol for Patients With Small Cell Lung Cancer

July 16, 2025 updated by: Shadia Jalal, Indiana University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shadia I. Jalal, MD
  • Phone Number: 317-274-3589
  • Email: sjalal@iu.edu

Study Contact Backup

  • Name: Gabby Kline, BA
  • Phone Number: (317) 278-2514
  • Email: gabkline@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Sidney and Lois Eskenazi Hospital
        • Contact:
          • Shadia I. Jalal, MD
          • Phone Number: 317-274-3589
          • Email: sjalal@iu.edu
        • Contact:
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
        • Contact:
          • Shadia I. Jalal, MD
          • Phone Number: 317-274-3589
          • Email: sjalal@iu.edu
        • Contact:
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Roudebush VA Medical Center
        • Contact:
          • Shadia Jalal, MD
          • Phone Number: 317-274-3589
          • Email: sjalal@iu.edu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any patient with active SCLC being seen at IUSCCC clinics.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Active SCLC Diagnosis
Procedure: Biospecimen Collection
Lung, liver, skin, subcutaneous metastases, and blood specimens may be collected via rapid autopsy within 10 hours of expiration.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Shadia I. Jalal, MD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

June 2, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO-IUSCCC-0783

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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