NCT04371198

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 18, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2022

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 28, 2023

Completed
Last Updated

August 28, 2023

Status Verified

October 1, 2022

Enrollment Period

1.9 years

First QC Date

April 29, 2020

Results QC Date

October 11, 2022

Last Update Submit

October 11, 2022

Conditions

Rectum Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Biopsies That Form Spherical Organoids

    Baseline

Study Arms (1)

Organoid

EXPERIMENTAL
Other: Biopsy

Interventions

BiopsyOTHER

Tissue biopsy

Organoid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years old.
  • Able to provide informed consent.
  • Undergoing proctoscopy.

You may not qualify if:

  • \. Patient not planned to receive neoadjuvant radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Results Point of Contact

Title
Joan Cahill BNS OCN CCRP
Organization
Duke University Health System
Joan.Cahill@duke.edu
(919) 668-5211

Study Officials

  • Brian Czito, MD

    Duke Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 1, 2020

Study Start

September 18, 2020

Primary Completion

August 17, 2022

Study Completion

August 17, 2022

Last Updated

August 28, 2023

Results First Posted

August 28, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

Data and organoids may be shared with other researchers

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
6 months after publication
Access Criteria
Researchers should request data and/or organoid lines from the principal investigator

Locations

US(1)