RNA Precision Oncology in Advanced Pancreatic Cancer (HIPPOCRATES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04476537|
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : March 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Other: OncoTreat||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Identification of Personalized Treatment Utilizing Master Regulator Gene Targets in Pancreatic Cancer|
|Estimated Study Start Date :||April 2021|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
Experimental: Intervention Arm
Individuals who meet the eligibility criteria based on their provided tissue sample will be followed by the investigators to obtain medical information every 4 weeks. This follow-up will consist of a review of medical records, contact with the participant's treating physician, or personal contact between the participant and the investigators at Columbia University Irving Medical Center (CUIMC). During the study, their tumor tissue will be evaluated to identify medications that may help treat the cancer. The results of these tests will be reviewed by experts on a Precision Medicine Tumor Board (PMTB) and these experts may recommend a specific treatment to the participant or participant's physician.These participants will continue to be followed until death or withdrawal of consent from the study.
OncoTreat is a computational pipeline that begins with a tumor expression profile and ends with a list of several candidate regimens.
No Intervention: Observation Arm
Individuals who do not meet the eligibility criteria based on their provided tissue sample will be provided follow-up with their treating physicians up to every 4 weeks to gather clinical information related to their disease.
- Number of participants assigned therapy with OncoTreat [ Time Frame: 36 months ]The primary outcome of the study is whether a subject is assigned a therapy that they are able to begin on Part 2 of this study. Assigment of therapy is based on results from OncoTreat analysis and recommendations of the Precision Medicine Tumor Board (PMTB) which included assessment of availability and expected toxicity of identified agents.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476537
|Contact: Research Nurse Navigator||(212) email@example.com|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Rachael A Safyan, MD 646-317-2321 firstname.lastname@example.org|
|Principal Investigator: Rachael A Safyan, MD|
|Principal Investigator:||Rachael A. Safyan, MD||Columbia University Irving Medical Center|