Universal Biospecimen Collection Protocol for Extra Mater... | NCT07218939

Studies
Universal Biospecimen Collection Protocol for Extra Material From Clinical Pulmonary Procedures

NCT07218939

Sponsor

M.D. Anderson Cancer Center

Status

Recruiting

Last Update Posted

May 19, 2026Actual

Enrollment

12,000Estimated

Phase

Not provided

Conditions

Pulmonary

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2025-07702	Other Identifier	NCI-CTRP Clinical Trials Registry

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 8, 2025Actual

Primary Completion Date

Dec 1, 2030Estimated

Completion Date

Dec 1, 2032Estimated

First Submitted Date

Oct 17, 2025

First Submission Date that Met QC Criteria

Oct 17, 2025

First Posted Date

Oct 21, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2026

Last Update Posted Date

May 19, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this study is to develop a biospecimen collection protocol for unused biospecimens from pulmonary procedures in order to facilitate research across many different areas of pulmonary medicine and mitigate the pulmonary morbidity experienced by patients with cancer.

Detailed Description

Primary objectives:

To assemble a tissue/blood bank biorepository for laboratory translational research by collecting extra samples of bronchoalveolar lavage, pleural fluid, blood or other residual tissue obtained during normally scheduled clinical procedures for the evaluation of pulmonary toxicity

To collect basic data on patient data and suspected pulmonary toxicity to cross-reference eligible biospecimens

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and Adverse Events (AEs)	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0	Through study completion; an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients over the age of 18, who are seen in the Cardiopulmonary Center and are undergoing pulmonary procedures

Exclusion Criteria:

Pregnant women and prisoners

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients scheduled for pulmonary procedures in the Cardiopulmonary Center are eligible to be approached for consent and enrollment into this observational biospecimen collection protocol.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ajay Sheshadri, MD	Contact	(713) 563-1987		asheshadri@mdanderson.org

Overall Officials

Name	Affiliation	Role
Ajay Sheshadri, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas M. D. Anderson Cancer Center	Recruiting	Houston	Texas	77030	United States