The Role of the Muscle-nervous System Interface in Cancer Cachexia (NUMANCAN)

March 18, 2018 updated by: Alessandro Laviano, University of Roma La Sapienza
Sarcopenia is an important component of cachexia associated with cancer, and their high incidence in cancer patients emphasizes the need for a better understanding of its mechanisms, which can result in better therapeutic interventions to reverse this situation and improve the prognosis. Our hypothesis is that the plasma concentration of IL-6 and c-terminal agrin is directly correlated with the loss of muscle mass and development of cachexia.

Study Overview

Status

Unknown

Conditions

Detailed Description

The agrin is a protein that acts on neuromuscular junctions (NMJs) promoting stabilization of same, which results in the maintenance and growth of muscle fibers, but the cleavage of agrin, a process by which is formed the agrin fragment C-terminus (CAF), has been linked to the development of sarcopenia, because its presence is directly linked to the reduction in the number of muscle fibers, increasing the heterogeneity of fiber size, presence of Central cores and increasing the proportion of type I fibers and consequently a greater degradation of lean body mass. Studies in mice show that the greatest cleavage of agrin carries on development of sarcopenia and human studies report that individuals with higher serum levels of sarcopenia CAF compared to individuals without sarcopenia.

Therefore, aiming at the complexity of cancer associated with the cachexia and the great importance of the maintenance of lean body mass to a better prognosis in disease, is of fundamental importance to elucidate the role of CAF and the factors associated with sarcopenia, the possible use of these proteins for diagnosis and the contribution that this clarification could bring in clinical therapy.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00185
        • Recruiting
        • Department of Clinical Medicine, Sapienza University of Rome
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Oure sample will be selected between cancer patient of Rome Umberto I Hospital

Description

Inclusion Criteria:

  • cancer diagnosis

Exclusion Criteria:

  • continuously use of anti-inflammatory medications;
  • present renal and/or liver failure,
  • AIDS,
  • inflammatory bowel disease or chronic inflammatory processes not related to cachexia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Group with cancer cachexia (CTB)
For diagnosis of cachexia it will be used the following criteria (Evans et al., 2008)
Group without cancer cachexia (TB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agrin fragment c-terminus CAF in cancer and cancer cachexia
Time Frame: 1 month
To measure the contents of agrin fragment c-terminus (CAF) in plasma of patient with cancer and cancer cachexia.
1 month
Agrin fragment c-terminus CAF in cancer sarcopenia
Time Frame: 1 month
To analyze correlation between Agrin fragment c-terminus CAF and the lean body mass (CT-scan estimated) of patients with cancer and with cancer cachexia.
1 month
Agrin fragment c-terminus CAF and IL-6 levels
Time Frame: 1 month
To correlate levels of agrin fragment c-terminus (CAF) and IL-6 plasma levels in patients with cancer and with cancer cachexia.
1 month
Agrin fragment c-terminus (CAF) and IL-6 and lean body mass
Time Frame: 1 month
To correlate levels of agrin fragment c-terminus (CAF) and IL-6 with the lean body mass
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Principal Investigator: Alessandro Laviano, MD, Department of Clinical Medicine, Sapienza University of Rome, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2018

Primary Completion (Anticipated)

April 16, 2018

Study Completion (Anticipated)

April 30, 2018

Study Registration Dates

First Submitted

March 11, 2018

First Submitted That Met QC Criteria

March 18, 2018

First Posted (Actual)

March 26, 2018

Study Record Updates

Last Update Posted (Actual)

March 26, 2018

Last Update Submitted That Met QC Criteria

March 18, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUMANCAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

We are still evaluate a researcher to analyze data collected

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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