NCT05889546

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
69mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Aug 2022Dec 2031

Study Start

First participant enrolled

August 31, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

8.3 years

First QC Date

May 22, 2023

Last Update Submit

July 16, 2025

Conditions

Keywords

Lung CancerSmall Cell Lung CancerFuture Research

Outcome Measures

Primary Outcomes (2)

  • 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

    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

Study Arms (1)

Active SCLC Diagnosis

Procedure: Biospecimen Collection

Interventions

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

Active SCLC Diagnosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient with active SCLC being seen at IUSCCC clinics.

You may qualify if:

  • ≥ 18 years old at the time of informed consent
  • Written informed consent and HIPAA authorization for release of personal health information.
  • Active SCLC diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Roudebush VA Medical Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Small Cell Lung CarcinomaLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Shadia I. Jalal, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabby Kline, BA

CONTACT

Shadia I. Jalal, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in the Department of Medicine at Indiana University

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 5, 2023

Study Start

August 31, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2031

Last Updated

July 20, 2025

Record last verified: 2025-07

Locations