Pancreatic Cancer, AdultCDNPANNCT03042442
Relation Between Cachexia, Diabetes and periNeural Invasion in PANcreatic Cancer- Biomarkers Substudy
An observational study of Pancreatic Cancer, Adult and Cachexia, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Cancer, Adult, Cachexia, Pain
- What is being tested?
- Point-of care biomarkers, Clinical, venous blood samples, pancreatic tissue and Follow-up
- How many people
- 114 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2017to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Age over 18 years old
- EUS or surgery biopsy confirming the diagnosis of adenocarcinoma
- Informed consent
Who cannot join
- obvious malabsorption
- artificial nutrition
- hyperthyroidism
- major depression
- other causes of malnutrition
- refusing to enter the study
Trial locations and contacts
1 site in 1 country.
Romania1 site
Regional Institute of Gastroenterology and Hepatology
Cluj-Napoca, Cluj, 400192
About this study
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.
Read the 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.
- Conditions
- Pancreatic Cancer, Adult, Cachexia, Pain, Diabetes Mellitus
- Being tested
- Point-of care biomarkers, Clinical, venous blood samples, pancreatic tissue, Follow-up
- Keywords
- pancreatic cancer, cachexia, perineural invasion, pain, diabetes
- Medical subject headings
- Pancreatic cancer, adult, Cachexia, Pain, Diabetes Mellitus, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of care biomarkersDiagnostic test
Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC
Clinical, venous blood samples, pancreatic tissueOther
Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.
Follow-upOther
Participants will be assessed (by telephone) over a period of 2 years
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Point-of care biomarkers; Other: Clinical, venous blood samples, pancreatic tissue; Other: Follow-up | |
| health patients (controls) | Health patients Receives: Diagnostic Test: Point-of care biomarkers; Other: Clinical, venous blood samples, pancreatic tissue; Other: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with loss of > 5% body weight
Using the BMI at admission and BMI at 6 months after admission
Measured: up to 6 months
Secondary outcomes (4)
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
Measured: up to 12 Months
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
Measured: Change from baseline at 12 months
Food intake assessment of participants using SNAQ questionnaire
At baseline, throughout and at the end of the study using SNAQ questionnaire
Measured: Change from baseline at 6 months
Assessing the survival rate by phone-calls follow-up every 6 months, up to 2 years
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Jan 2017
- Primary completion30 Jun 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livia Petrusel, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Livia Petrusel, MD, PhD, Principal investigator, Iuliu Hatieganu University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042442
- Sponsor's protocol ID
- PCD 769/36
- Acronym
- CDNPAN
- Status last verified
- Mar 2019
- First submitted
- 24 Jan 2017
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Cachexia, Diabetes and periNeural Invasion in PANcreatic Cancer- Biomarkers Substudy
- ClinicalTrials.gov ID
- NCT03042442
- Acronym / sponsor ID
- CDNPAN / PCD 769/36
- Conditions
- Pancreatic Cancer, Adult, Cachexia, Pain, Diabetes Mellitus
- Keywords
- pancreatic cancer, cachexia, perineural invasion, pain, diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pancreatic cancer | – | Diagnostic Test: Point-of care biomarkers, Other: Clinical, venous blood samples, pancreatic tissue, Other: Follow-upPatients 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. |
| health patients (controls) | – | Diagnostic Test: Point-of care biomarkers, Other: Clinical, venous blood samples, pancreatic tissue, Other: Follow-upHealth patients |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age over 18 years old
- EUS or surgery biopsy confirming the diagnosis of adenocarcinoma
- Informed consent
Key exclusion criteria (6 listed)
- obvious malabsorption
- artificial nutrition
- hyperthyroidism
- major depression
- other causes of malnutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of care biomarkersPoint-of care biomarkers(Activin,Midkine) assessed by WB and IHC | Diagnostic test | Patients with pancreatic cancer, health patients (controls) |
| Clinical, venous blood samples, pancreatic tissueClinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers. | Other | Patients with pancreatic cancer, health patients (controls) |
| Follow-upParticipants will be assessed (by telephone) over a period of 2 years | Other | Patients with pancreatic cancer, health patients (controls) |
Primary outcome
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
4 secondary outcomes
Number of participants with pain as main symptom and antialgic therapy
Time frame: up to 12 Months
Evaluation of Quality of Life of participants (EORTC QLQ-C30 )
Time frame: Change from baseline at 12 months
Food intake assessment of participants using SNAQ questionnaire
Time frame: Change from baseline at 6 months
Assessing the survival rate by phone-calls follow-up every 6 months, up to 2 years
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Livia Petrusel, MD, PhD principal investigator
Iuliu Hatieganu University of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, Adult and Cachexia, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with loss of > 5% body weight (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.