RNA Precision Oncology in Advanced Pancreatic Cancer

NCT04476537 | Terminated Results DMC FDA Device

• 1 other identifier: AAAR6703
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic ductal adenocarcinoma (PDA); Precision medicine

Outcome Measures

Primary Outcomes (1)

• Number of Participants Assigned Therapy With OncoTreat

  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

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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

Interventions

OncoTreat DEVICE

OncoTreat is a computational pipeline that begins with a tumor expression profile and ends with a list of several candidate regimens.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Gulam Manji, MD
• Organization: Columbia University

gam2140@cumc.columbia.edu

212-342-5162

Study Officials

• Gulam Manji, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: December 7, 2020
• Primary Completion: July 15, 2022
• Study Completion: March 31, 2023
• Last Updated: April 3, 2025
• Results First Posted: April 3, 2025

Record last verified: 2025-03

Locations

US (1)