NCT01533909

Brief Summary

The aim of the study is to develop a screenings tool that will enable hospital nurses to detect and stage cancer cachectic patients. The early detection and staging of cancer cachexia will assist the oncology team in providing the cachectic cancer patient tailor-made patient care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 3, 2014

Status Verified

March 1, 2012

Enrollment Period

1.2 years

First QC Date

February 10, 2012

Last Update Submit

December 2, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Nutritional Assessment

    Patient-Generated Subjective Global Assessment Instrument is a measure for the nutritional status of the participants. The final score of this instruments devides participants into three categories: well-nourished, moderately nourished or suspected malnourished.

    4 times in 6 months

Secondary Outcomes (3)

  • Quality of Life

    4 times in 6 months

  • Anthropometric measurements

    4 times in 6 months

  • Markers of inflammation/metabolic disturbance

    4 times in 6 months

Study Arms (1)

Cancer patients

As this is not an intervention study there is only one cohort. Patients that will be included and excluded are described in the eligibility section.

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population from which the groups or cohorts will be selected (e.g., primary care clinic, community sample, residents of a certain town). (Limit: 1000 characters)

You may qualify if:

  • New Diagnosed Patients With Primary Head and Neck Cancer Neoplasms
  • New Diagnosed Patients With Metastatic Pancreatic Neoplasms
  • New Diagnosed Patients With Metastatic Colonic Neoplasms

You may not qualify if:

  • Patients With Other Primary Neoplasms
  • Patients Already in Therapy
  • Patients With Non-metastatic Colonic or Pancreatic Neoplasms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The blood sample that will be collected is part of the routine hospital assessment. The biomarkers that will be measured are albumine, creatine, CRP, hemoglobin and Lactate dehydrogenase (LDH).

MeSH Terms

Conditions

Cachexia

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Study Officials

  • Ignace Vergote, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2012

First Posted

February 15, 2012

Study Start

March 1, 2012

Primary Completion

May 1, 2013

Study Completion

September 1, 2013

Last Updated

December 3, 2014

Record last verified: 2012-03

Locations