Plasma Biomarkers P-DAC, V1

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

169 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-26

Study Completion Date

2021-12-31

Brief Summary

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This is an exploratory, translational, non-interventional and multi-centre clinical study. The aim of the study is to identify predictive plasma biomarkers of response to chemotherapy in PDAC.

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Detailed Description

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This study will involve two cohort groups, all patients involved will have PDAC.

Cohort A: Target is 80 resectable PDAC patients who will receive standard treatment of chemotherapy +/- radiotherapy

Cohort B:

* Cohort B1 = Target is 80 unresectable locally advanced PDAC patients who will receive standard treatment of chemotherapy +/- radiotherapy.
* Cohort B2 = Target is metastatic PDAC patients who will receive standard treatment of chemotherapy +/- radiotherapy.

Control patients: Target is 50, with acute pancreatitis admitted to hospital for observation/treatment.

Blood samples will be taken at the following time points:

* prior to resection, whenever feasible for cohort A
* prior to CT, for both cohort A and B
* during CT, for both cohort A and B
* follow-up, approximately every 3 to 6 months for two years for cohort A

Conditions

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Pancreatic Ductal Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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B

Unresectable or metastatic PDAC patients who will receive standard treatment of CT +/- radiotherapy

No interventions assigned to this group

A

Resectable PDAC patients who will receive standard treatment of CT +/- radiotherapy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years of age
* Ability to give written informed consent
* Histologically or cytologically-confirmed PDAC
* Patients who will receive standard treatment of CT +/- radiotherapy and present with:

Cohort A: resectable cancer OR Cohort B.1: unresectable locally advanced cancer OR Cohort B.2: metastatic cancer

* Eastern Cooperative Oncology Group (ECOG) Performance status 0 - 2

Exclusion Criteria

* Presence of medical or psychiatric conditions, which, in the opinion of the investigator, would potentially pose a risk to the patient in participating in this study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No