Clinical trial NCT03042442: Relation Between Cachexia, Diabetes and periNeural Invasion in PANcreatic Cancer- Biomarkers Substudy
Official title: Relation Between Cachexia, Diabetes and periNeural Invasion in PANcreatic Cancer- Biomarkers Substudy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer, Adult
Cachexia
Pain
Diabetes Mellitus
Keywords: pancreatic cancer
cachexia
perineural invasion
pain
diabetes
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of patients with loss of > 5% body weight
timeFrame: up to 6 months
Secondary outcomes:
measure: Number of participants with pain as main symptom and antialgic therapy
timeFrame: up to 12 Months
measure: Evaluation of Quality of Life of participants (EORTC QLQ-C30 )
timeFrame: Change from baseline at 12 months
measure: Food intake assessment of participants using SNAQ questionnaire
timeFrame: Change from baseline at 6 months
measure: Assessing the survival rate by phone-calls follow-up every 6 months, up to 2 years
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Cluj Napoca
country: Romania
facility: Regional Institute of Gastroenterology and Hepatology
state: Cluj
Study officials:
affiliation: Iuliu Hatieganu University of Medicine
name: Livia Petrusel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: