- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05889546
Rapid Autopsy Protocol for Patients With Small Cell Lung Cancer
July 12, 2026 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
-
-
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:
- Gaby Kline, BA
- Phone Number: (317) 278-2514
- Email: gabkline@iu.edu
-
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:
- Gabby Kline, BA
- Phone Number: (317) 278-2514
- Email: gabkline@iu.edu
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Roudebush VA Medical Center
-
Contact:
- Shadia Jalal, MD
- Phone Number: 317-274-3589
- Email: sjalal@iu.edu
-
Contact:
- Cynthia Johnson
- Phone Number: (317) 278-7403
- Email: cydjohns@iu.edu
-
-
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:
- ≥ 18 years old at the time of informed consent
- Written informed consent and HIPAA authorization for release of personal health information.
- 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
|
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
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 14, 2026
Last Update Submitted That Met QC Criteria
July 12, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
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.