Health TrialsbyHealthPanel

A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

ConditionsPancreatic CancerPancreatic DiseasesPancreatitisPancreatic Cyst
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

The purpose of this study is to develop a minimally invasive test to diagnose pancreatic cancer at early stages of disease and monitor response to treatment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Radiological, histological or cytological confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma by the enrolling institution

Patient planning to receive systemic treatment

Hemoglobin > 8

ECOG performance status 0-2

Disqualifiers

Prior chemotherapy or radiation therapy for pancreatic cancer within the last 3 months in the localized setting

Active second malignancy, unless low grade malignancy

Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Neoadjuvant chemotherapy or radiation therapy is planned

Trial population

Potential research subjects in the PDAC and benign pancreatic disease cohorts will be identified by a member of the patient's treatment team, the principal investigator, or research team at MSK or participating institutions. If the investigator is a member of the treatment team, s/he will screen their patients' medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. The investigator will use information provided by the patient and/or medical record to confirm that the patient is eligible and contact the patient regarding study enrollment. Healthy controls will be recruited from patients from outpatient primary care clinics at non-MSK sites and volunteers from which may include the staffs members at collaborating sites.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Blood Draw

    Diagnostic test

    If clinically safe, up to approximately 50ml of blood will be drawn, not to exceed the following criteria: Patients and controls weighing 50kg or more * For draw amounts up to 50mL, there is no required hemoglobin threshold. * For amounts exceeding 50mL, patients who meet standard blood banking criteria (e.g., hemoglobin values within normal limits and minimum weight of 50kg) may give as much as a full unit of blood (500mL) at one time or in divided fractions over a 56 day/eight week period. Patients and controls weighing \< 50kg * For patients whose hemoglobin is below normal limits but at least 7.0 gm/dL, no more than a total of 50 ml of blood or 5 ml/kg, whichever is less, may be collected per 56 day/eight week period, but no more than approximately 2 ml/kg of blood at any one time.

  • Tumor Tissue Collection

    Diagnostic test

    Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere

  • Cyst Fluid

    Diagnostic test

    Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere

Treatment groups

120 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Cohort 1: Advanced PDAC cohort2 interventions
Group B: Cohort 2: Operable PDAC cohort2 interventions
Group C: Cohort 3: Acute Benign Pancreatic Pathology Cohort1 intervention
Group D: Cohort 4: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts2 interventions
Group E: Cohort 5: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts2 interventions
Group F: Cohort 6: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts2 interventions
Group G: Cohort 7: Healthy Controls1 intervention

Trial outcomes

Primary outcomes

1

Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer

Time frame
4 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Sheba Medical Center

Collaborator

Weill Medical College of Cornell University

Collaborator

Weizmann Institute of Science

Collaborator

Source ClinicalTrials.gov
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