Patient-Derived Organoids for Rectal Cancer

October 11, 2022 updated by: Duke University

Feasibility of Establishing Patient-Derived Organoids for Rectal Cancer: A Biospecimen Collection Protocol

The purpose of this study is to determine the feasibility of establishing patient-derived organoids from pre-treatment rectal adenocarcinoma biopsies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Cancer Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion

  1. Age ≥18 years old.
  2. Able to provide informed consent.
  3. Undergoing proctoscopy.

Exclusion

1. Patient not planned to receive neoadjuvant radiotherapy

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Organoid
Other: Biopsy
Tissue biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Biopsies That Form Spherical Organoids
Time Frame: Baseline
Baseline

Collaborators and Investigators

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

Sponsor

Duke University

Investigators

  • Principal Investigator: Brian Czito, MD, Duke Health

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)

September 18, 2020

Primary Completion (Actual)

August 17, 2022

Study Completion (Actual)

August 17, 2022

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

May 1, 2020

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00104561

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data and organoids may be shared with other researchers

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

Researchers should request data and/or organoid lines from the principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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