RNA Precision Oncology in Advanced Pancreatic Cancer (HIPPOCRATES)

March 19, 2024 updated by: Gulam Manji, Columbia University

Identification of Personalized Treatment Utilizing Master Regulator Gene Targets in Pancreatic Cancer

The overall objective of this project is to determinate the feasibility of administering personalized therapy to subjects with advanced pancreatic cancer utilizing the novel OncoTreat platform. The primary objective of this study is to assess the feasibility of implementing the OncoTreat framework in patients with newly diagnosed, untreated metastatic pancreatic adenocarcinoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Pancreatic ductal adenocarcinoma (PDA) is a major health problem in the United States and throughout the world. Pancreatic ductal adenocarcinoma (PDA) has the worst prognosis of any major malignancy in the United States and, unlike other common cancers, annual deaths from PDA are rising. During 2017, it is estimated that 53,670 people were diagnosed with PDA and approximately 43,090 people died from PDA in the U.S. Despite recent advances, cytotoxic chemotherapy for PDA has been disappointing with response rates of 20-30% for the most active regimens and little activity for targeted therapies. Even among the small subset of patients who are suitable for surgical resection at the time of diagnosis, complete resection is followed by recurrence in >90% of patients without further systemic therapy, with a median time to recurrence of 6.9 months. Thus all PDA patients require systemic chemotherapy and more effective regimens are urgently needed.

Study Type

Interventional

Enrollment (Estimated)

30

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
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical 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 Criteria:

  • Be willing and able to provide written informed consent for the trial.
  • Age ≥18 years of age on day of signing informed consent.
  • Have histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma or be willing to undergo a biopsy with confirmed pathology prior to starting therapy.
  • Have untreated disease that is unresectable due to being metastatic or locally advanced without potential of surgery as assessed by the treating physician.
  • Subjects who have documented disease recurrence greater than 6 months after completing neoadjuvant or adjuvant chemotherapy for limited disease will be eligible for the study.
  • Have a predicted life expectancy of greater than 6 months.
  • Subjects must have a plan to obtain a new core biopsy of a primary and/or metastatic lesion planned as part of routine care for which consent is obtained separately or (b) consent to be biopsied to satisfy the tissue requirements of this protocol.

Exclusion Criteria:

Has previously received neoadjvuant or adjuvant chemotherapy for pancreatic cancer unless greater than 6 months has passed since completion of adjuvant or neoadjuvant chemotherapy and initiation of therapy for recurrent or metastatic disease.

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: OncoTreat
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. Assignment 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.
36 months

Collaborators and Investigators

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

Sponsor

Columbia University

Investigators

  • Principal Investigator: Rachael A. Safyan, MD, Columbia University

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)

August 10, 2018

Primary Completion (Actual)

March 17, 2023

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

July 15, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAR6703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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.

Clinical Trials on Pancreatic Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe