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2020-12-07
2022-07-15
2023-03-31
16
NCT04476537
Columbia University
Columbia University
INTERVENTIONAL
RNA Precision Oncology in Advanced 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.
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. Previous versions of this record contained reference to an observational arm in error. The observational arm has been removed from the record for consistency with the study protocol.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-07-15 | 2025-03-18 | 2025-03-18 |
2020-07-15 | 2025-03-18 | 2025-04-03 |
2020-07-20 | 2025-04-03 | 2025-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
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 | DEVICE: OncoTreat
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
