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Completed

NCT Number: NCT03042442

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

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.

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Key information

Conditions

Pancreatic Cancer, Adult Body Weight Body Weight Changes Cachexia Diabetes Mellitus Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Regional Institute of Gastroenterology and Hepatology

Cluj-Napoca, Cluj, 400192, Romania

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Point-of care biomarkers

Diagnostic Test

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

Clinical, venous blood samples, pancreatic tissue

Other

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

Follow-up

Other

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

Primary outcomes

  1. Rate of patients with loss of > 5% body weight

    Time frame: up to 6 months

    Using the BMI at admission and BMI at 6 months after admission

Secondary outcomes

  1. Number of participants with pain as main symptom and antialgic therapy

    Time frame: up to 12 Months

    At baseline, throughout and at the end of the study as assessed by Visual Analogue Scale and type of antialgic treatment

  2. Evaluation of Quality of Life of participants (EORTC QLQ-C30 )

    Time frame: Change from baseline at 12 months

    At baseline, throughout and at the end of the study using EORTC QLQ-C30 questionnaire

  3. Food intake assessment of participants using SNAQ questionnaire

    Time frame: Change from baseline at 6 months

    At baseline, throughout and at the end of the study using SNAQ questionnaire

  4. Assessing the survival rate by phone-calls follow-up every 6 months, up to 2 years

    Time frame: up to 2 years

Sponsors and collaborators

Lead sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Other

Registry information

Acronym: CDNPAN

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 3, 2017
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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