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

Iuliu Hatieganu University of Medicine and Pharmacy

Status: Completed

Conditions: Pancreatic Cancer, Adult; Diabetes Mellitus; Cachexia; Pain

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

Study type: Observational

Funder types: Other

Identifiers

NCT03042442

PCD 769/36

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

114 participants in 2 patient groups

Patients with pancreatic cancer

Description:

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.

Treatment:

Other: Follow-up

Other: Clinical, venous blood samples, pancreatic tissue

Diagnostic Test: Point-of care biomarkers

health patients (controls)

Description:

Health patients

Treatment:

Other: Follow-up

Other: Clinical, venous blood samples, pancreatic tissue

Diagnostic Test: Point-of care biomarkers