Relation Between Cachexia, Diabetes and periNeural Invasion in PANcreatic Cancer- Biomarkers Substudy
NCT ID: NCT03042442
Last Updated: 2019-03-19
Study Results
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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COMPLETED
114 participants
OBSERVATIONAL
2017-01-01
2018-09-30
Brief Summary
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Detailed Description
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Patients with pancreatic ductal adenocarcinoma, based on the results of an endoscopic ultrasonography (EUS) biopsy or surgery were enrolled at the diagnosis and blood samples are drawn.
Thus the investigators propose to identify the protein expression levels of Activin and Midkine in plasma of patients with different stages of pancreatic adenocarcinoma compared with benign pancreatic disorders and healthy patients and to evaluate the possible correlation with diabetes, tumor size and tumor stage.
Furthermore, the investigators propose to identify the prognostic role of these biomarkers in the development of metastasis and survival in patients with adenocarcinoma, with and without diabetes and cachexia; to identify a new biomarker predictive of cachexia and eventually to select patients likely to benefit from treatment with antagonists of activin (or hypoglycemic treatment) and investigating the role of invasion neural in the appearance of cachexia in patients with pancreatic adenocarcinoma.
Follow-up: with phone-calls on an every 6 month, for up to 2 years, retaining the following data: survival, date of decease and its direct cause, the presence of tumor recurrence.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients with pancreatic cancer
Patients with pancreatic ductal adenocarcinoma, based on the results of an endoscopic ultrasonography (EUS) biopsy or surgery were enrolled at the diagnosis, before any therapeutic intervention.
Point-of care biomarkers
Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC
Clinical, venous blood samples, pancreatic tissue
Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.
Follow-up
Participants will be assessed (by telephone) over a period of 2 years
health patients (controls)
Health patients
Point-of care biomarkers
Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC
Clinical, venous blood samples, pancreatic tissue
Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.
Follow-up
Participants will be assessed (by telephone) over a period of 2 years
Interventions
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Point-of care biomarkers
Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC
Clinical, venous blood samples, pancreatic tissue
Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.
Follow-up
Participants will be assessed (by telephone) over a period of 2 years
Eligibility Criteria
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Inclusion Criteria
2. EUS or surgery biopsy confirming the diagnosis of adenocarcinoma
3. Informed consent
Exclusion Criteria
2. artificial nutrition
3. hyperthyroidism
4. major depression
5. other causes of malnutrition
6. refusing to enter the study
18 Years
100 Years
ALL
No
Sponsors
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Iuliu Hatieganu University of Medicine and Pharmacy
OTHER
Responsible Party
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Livia Petrusel
MD, PhD Student
Principal Investigators
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Livia Petrusel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Iuliu Hatieganu University of Medicine
Locations
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Regional Institute of Gastroenterology and Hepatology
Cluj-Napoca, Cluj, Romania
Countries
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Other Identifiers
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PCD 769/36
Identifier Type: -
Identifier Source: org_study_id
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