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RNA Precision Oncology in Advanced Pancreatic Cancer (HIPPOCRATES)

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ClinicalTrials.gov Identifier: NCT04476537
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : November 30, 2022
Information provided by (Responsible Party):
Gulam Manji, Columbia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Device: OncoTreat Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Identification of Personalized Treatment Utilizing Master Regulator Gene Targets in Pancreatic Cancer
Actual Study Start Date : August 10, 2018
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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

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Contact: Research Nurse Navigator (212) 342-5162 cancerclinicaltrials@cumc.columbia.edu

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United States, New York
Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Rachael A. Safyan, MD    646-317-2321    rs2263@cumc.columbia.edu   
Principal Investigator: Rachael A. Safyan, MD         
Sponsors and Collaborators
Columbia University
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Principal Investigator: Rachael A. Safyan, MD Columbia University
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Responsible Party: Gulam Manji, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT04476537    
Other Study ID Numbers: AAAR6703
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: November 30, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gulam Manji, Columbia University:
Pancreatic ductal adenocarcinoma (PDA)
Precision medicine
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases