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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Diabetes Mellitus; Cachexia; Pancreatic Cancer, Adult
• Intervention / Treatment: Diagnostic test: Point-of care biomarkers; Other: Clinical, venous blood samples, pancreatic tissue; Other: Follow-up

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• Romania
  • Cluj
    • Cluj Napoca, Cluj, Romania, 400192
      • Regional Institute of Gastroenterology and Hepatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Subjects of the study group were at least 18 years old, with no previous history of any other cancer in the last 5 years. Written consent was given prior to entry into the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Point-of care biomarkers; Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC; Other: Clinical, venous blood samples, pancreatic tissue; Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.; Other: Follow-up; Participants will be assessed (by telephone) over a period of 2 years
health patients (controls); Health patients	Diagnostic test: Point-of care biomarkers; Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC; Other: Clinical, venous blood samples, pancreatic tissue; Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.; Other: Follow-up; Participants will be assessed (by telephone) over a period of 2 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients with loss of > 5% body weight	Using the BMI at admission and BMI at 6 months after admission	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with pain as main symptom and antialgic therapy	At baseline, throughout and at the end of the study as assessed by Visual Analogue Scale and type of antialgic treatment	up to 12 Months
Evaluation of Quality of Life of participants (EORTC QLQ-C30 )	At baseline, throughout and at the end of the study using EORTC QLQ-C30 questionnaire	Change from baseline at 12 months
Food intake assessment of participants using SNAQ questionnaire	At baseline, throughout and at the end of the study using SNAQ questionnaire	Change from baseline at 6 months
Assessing the survival rate by phone-calls follow-up every 6 months, up to 2 years		up to 2 years

Collaborators and Investigators

• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
• Investigators: Principal Investigator: Livia Petrusel, MD, PhD, Iuliu Hatieganu University of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 16, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: diabetes; pain; pancreatic cancer; cachexia; perineural invasion
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Nutrition Disorders; Body Weight; Body Weight Changes; Pancreatic Diseases; Emaciation; Weight Loss; Diabetes Mellitus; Pancreatic Neoplasms; Wasting Syndrome; Cachexia
• Other Study ID Numbers: PCD 769/36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No