Non-invasive Assessment of Skeletal Muscle Loss in Cancer... | NCT01015274

Studies
Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients

NCT01015274

Sponsor

The University of Texas Medical Branch, Galveston

Status

Completed

Last Update Posted

Jul 11, 2018Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Cachexia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 16, 2009

First Submission Date that Met QC Criteria

Nov 17, 2009

First Posted Date

Nov 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2018

Last Update Posted Date

Jul 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The long-term objective of this research is to develop a non-invasive approach for early assessment of which patients are at high risk for future development of skeletal muscle atrophy. The investigators hypothesize that the rate constant for the terminal portion of the isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine (D-3MH) provides an accurate measure of this increased risk and that this rate constant can be measured non-invasively from timed spot urine samples.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Label	Type	Description	Intervention Names
Healthy control male

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male
30-75 years old
Body Mass Index (BMI) <27 kg/m2

Exclusion Criteria:

Uncontrolled hypertension
Glomerular filtration rate less than 60 mL/min/1.73 m2
History of recurrent gastrointestinal bleeding
Unable or unwilling to provide informed consent
Ongoing anti-coagulant therapy

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

community sample of healthy males

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Morteza Janghorbani, Ph.D.	BIOCHEMANALYSIS CORPORATION	Principal Investigator
Melinda Sheffield-Moore, Ph.D.	University of Texas	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Medical Branch		Galveston	Texas	77555	United States

Condition Browse Module

MeSH Terms

ID	Term
D002100	Cachexia

Ancestor Terms

ID	Term
D015431	Weight Loss
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Link
1R43AR054993-01A,
AR054993
1R43AR054993-01	U.S. NIH Grant/Contract	View source