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

NCT03042442 | Completed DMC

• 1 other identifier: PCD 769/36
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer, Adult; Cachexia; Pain; Diabetes Mellitus

Keywords

pancreatic cancer; cachexia; perineural invasion; pain; diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of participants with pain as main symptom and antialgic therapy

  up to 12 Months

• Evaluation of Quality of Life of participants (EORTC QLQ-C30 )

  Change from baseline at 12 months

• Food intake assessment of participants 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

Study Arms (2)

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; Other: Clinical, venous blood samples, pancreatic tissue; Other: Follow-up

health patients (controls)

Health patients

Diagnostic Test: Point-of care biomarkers; Other: Clinical, venous blood samples, pancreatic tissue; Other: Follow-up

Interventions

Point-of care biomarkers DIAGNOSTIC_TEST

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

Patients with pancreatic cancer; health patients (controls)

Clinical, venous blood samples, pancreatic tissue OTHER

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

Patients with pancreatic cancer; health patients (controls)

Follow-up OTHER

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

Patients with pancreatic cancer; health patients (controls)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age over 18 years old
• EUS or surgery biopsy confirming the diagnosis of adenocarcinoma
• Informed consent

You may not qualify if:

• obvious malabsorption
• artificial nutrition
• hyperthyroidism
• major depression
• other causes of malnutrition
• refusing to enter the study

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

Regional Institute of Gastroenterology and Hepatology

Cluj-Napoca, Cluj, 400192, Romania

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples and pancreatic cancer tissue (from EUS FNA and surgery) will be collected from patients with pancreatic cancer adenocarcinoma at the time of diagnosis. The blood sample will be immediately prepared by centrifugation at 5000 × g for 5 min. The plasma samples were stored at -80 °C until use. Tissue will be embedded in paraffin. Point-of-care bio-markers will be assessed by using western blot analyses and immunohistochemistry. The participant will be explicitly asked for consent for storing the plasma sample.

MeSH Terms

Conditions

Pancreatic cancer, adult; Cachexia; Pain; Diabetes Mellitus; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Neurologic Manifestations; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases

Study Officials

• Livia Petrusel, MD, PhD

  Iuliu Hatieganu University of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD Student

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: February 3, 2017
• Study Start: January 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: September 30, 2018
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)