PDAC Peripheral and Portal Vein Sampling
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04289961 |
Recruitment Status :
Completed
First Posted : February 28, 2020
Last Update Posted : August 30, 2023
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Condition or disease | Intervention/treatment | Phase |
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Pancreatic Adenocarcinoma | Diagnostic Test: Portal vein sampling | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Prospective translational research study |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | A Research Protocol for Collection of Peripheral and Portal Vein Blood From Patients With Pancreatic Adenocarcinoma for Translational Research |
Actual Study Start Date : | June 12, 2019 |
Actual Primary Completion Date : | April 6, 2022 |
Actual Study Completion Date : | April 6, 2023 |
Arm | Intervention/treatment |
---|---|
Single Arm
Observational study of CTC microemboli in portal vein blood samples.
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Diagnostic Test: Portal vein sampling
During Endoscopic UltraSound guided-Fine Needle Aspitation (EUS-FNA) a curvilinear echoendoscope is advanced to the distal stomach or duodenal bulb to provide a window of access to a branch of the PV. After verifying venous flow by Doppler signal, a 19-gauge EUS-FNA needle is advanced transhepatically into the portal vein branch. With the needle in the portal vein, the stylet is removed and negative-pressure suction is applied to aspirate blood. A transhepatic approach for portal vein branch access is an absolute requirement of this technique in order to minimize the risk of bleeding. The puncture site is monitored under EUS for complications. |
- Blood-borne biomarker analysis for PDAC [ Time Frame: 12 months ]To prospectively collect paired peripheral and portal vein serum, plasma and whole blood samples for translational research at various time points. To investigate the presence of Circulating Tumour Cells and Circulating Tumour Microemboli and their biological significance. To investigate potential prognostic and predictive blood-borne genetic, protein and/or messenger ribonucleic acid biomarkers using the collected specimens.
- Correlation of identified biomarkers with progression free and overall survival [ Time Frame: 24 months ]To prospectively collect progression free and overall survival data so that correlation between biomarker parameters and clinical parameters can be examined.
- Investigation germline genetic biomarkers [ Time Frame: 12-24 months ]Investigation of potential predictive blood germline genetic biomarkers using the collected specimens.
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with clinically-suspected or cytologically/histologically-proven Pancreatic Adenocarcinoma who have been referred for EUS-FNA. Patients who are already on treatment would also be eligible.
- Patients who are 18 years or older.
- Patients must be able to receive and understand verbal and written information regarding the study and give written informed consent.
- Patients must be able to comply with trial requirements.
Exclusion Criteria:
- Patients with other active malignancy would not be eligible with the exception of patients with squamous or basal cell carcinoma of the skin. An exception to this statement would be those patients with a known/suspected germ-line predisposition to suffer multiple malignancies, such as, but not limited to Hereditary Breast and Ovarian Cancer Syndrome (BRCA1/2), Lynch syndrome or multiple endocrine neoplasia (MEN) syndrome.
- Patient with INR >1.5 and/or platelets ≤50.
- Patients with bleeding disorders.
- Patients on anti-platelet or anti-coagulation treatment that cannot be temporarily discontinued around the procedure.
- Patients who cannot give informed consent.
- Patients with known Hepatitis C viral infection.
- Patients with known Human Immunodeficiency Virus (HIV) infection.
- If clinically judged by the investigator that the patient should not participate in the study.
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): NCT04289961
United Kingdom | |
Manchester University NHS Foundation Trust | |
Manchester, United Kingdom, M13 9WL | |
The Christie NHS Foundation Trust | |
Manchester, United Kingdom, M20 4BX |
Responsible Party: | Juan Valle, Professor of Medical Oncology, The Christie NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT04289961 |
Other Study ID Numbers: |
18_DOG03-436 |
First Posted: | February 28, 2020 Key Record Dates |
Last Update Posted: | August 30, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Identifiable personal data (IPD) will be reviewed by the investigators listed on the trial delegation log at the stage of reviewing the medical records during the hepatopancreatobiliary (HPB) MultiDisciplinary Team (MDT) meeting at Manchester University Foundation Trust where the recruitment process will start. The medical notes will also be reviewed to correlate biomarker research with clinical outcomes. However, no participants' identifiable information will be shared with anyone outside the clinical or research team. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Circulating Tumour Cells (CTCs) CTC clusters EUS-FNA Portal Vein Biomarkers |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |