Relation Between Cachexia, Diabetes and periNeural Invasion in PANcreatic Cancer- Biomarkers Substudy

NCT ID: NCT03042442

Last Updated: 2019-03-19

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

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-09-30

Brief Summary

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The purpose of this study is to determine the interrelationship between cachexia, neural invasion and diabetes in patients with pancreatic cancer. 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 healthy patients and to evaluate the possible correlation with diabetes, tumor size and tumor stage.

Detailed Description

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In this study, the investigators will prospectively evaluate pancreatic adenocarcinoma patients with or without cachexia, perineural invasion and diabetes.

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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Pancreatic Cancer, Adult Cachexia Pain Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC

Clinical, venous blood samples, pancreatic tissue

Intervention Type OTHER

Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.

Follow-up

Intervention Type OTHER

Participants will be assessed (by telephone) over a period of 2 years

health patients (controls)

Health patients

Point-of care biomarkers

Intervention Type DIAGNOSTIC_TEST

Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC

Clinical, venous blood samples, pancreatic tissue

Intervention Type OTHER

Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.

Follow-up

Intervention Type OTHER

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

Intervention Type DIAGNOSTIC_TEST

Clinical, venous blood samples, pancreatic tissue

Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.

Intervention Type OTHER

Follow-up

Participants will be assessed (by telephone) over a period of 2 years

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age over 18 years old
2. EUS or surgery biopsy confirming the diagnosis of adenocarcinoma
3. Informed consent

Exclusion Criteria

1. obvious malabsorption
2. artificial nutrition
3. hyperthyroidism
4. major depression
5. other causes of malnutrition
6. refusing to enter the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Livia Petrusel

MD, PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Romania

Other Identifiers

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PCD 769/36

Identifier Type: -

Identifier Source: org_study_id

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