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

Pain Clinical Trial

— CDNPAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042442
• Other study ID #: PCD 769/36
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: March 2019
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: September 30, 2018
• Est. primary completion date: June 30, 2018
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Carcinoma
• Diabetes Mellitus
• Pain
• Pancreatic Cancer, Adult
• Pancreatic Neoplasms

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.
• Follow-up
Participants will be assessed (by telephone) over a period of 2 years

Locations

Country	Name	City	State
Romania	Regional Institute of Gastroenterology and Hepatology	Cluj Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Assessing the survival rate by phone-calls follow-up every 6 months, up to 2 years		up to 2 years