Establishing a Platform for Personalized Approach to the Management of Rectal Adenocarcinoma Using Patient-Derived Tumoroids and Organoids
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 21-000230
Sponsor Protocol Number: 21-000230
About this study
The purpose of this study is to create a database of rectal cancer cells that can be studied outside of the patient's body.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 18 years of age.
- Have an ECOG Performance Status of ≤ 2.
- No evidence of distant metastasis on imaging.
- Histologic or cytologic proven adenocarcinoma of the rectum.
- Providing informed consent prior to enrollment in the trial.
Exclusion Criteria:
- Inability to obtain additional core needle biopsies for generating PDTOs.
- Patients who received colorectal cancer chemotherapy or pelvic radiation in the past 5 years.
- Females who are pregnant or plan to become pregnant.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Jeremy Jones, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available