NCT06060262

Brief Summary

The investigators conduct this prospective study and wish to elucidate the association of serial change of body composition, serum adipo-myokines and adverse effect of chemotherapy and lung cancer prognosis

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 2, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

2.8 years

First QC Date

September 24, 2023

Last Update Submit

September 24, 2023

Conditions

Keywords

adipo-myokinesbody compositionend stage lung cancerclinical outcomes

Outcome Measures

Primary Outcomes (13)

  • Number of white blood cell change among before, during and after cancer therapy

    assessing the change of white blood cell count among week 0, week 4 and week 12

    week 0 , week 4 and week 12 after cancer theraphy

  • Percentage of body fat change among before, during and after cancer therapy

    assessing the change of percentage of body fat among week 0, week 4 and week 12

    week 0 , week 4 and week 12 after cancer theraphy

  • Percentage of total body water change among before, during and after cancer therapy

    assessing the change of total body water percentage among week 0, week 4 and week 12

    week 0 , week 4 and week 12 after cancer theraphy

  • Percentage of soft lean mass change among before, during and after cancer therapy

    assessing the change of soft lean mass percentage among week 0, week 4 and week 12

    week 0 , week 4 and week 12 after cancer theraphy

  • Concentration of plasma CEA change among before, during and after cancer therapy

    assessing the change of plasma CEA concentration among week 0, week 4 and week 12

    week 0, week 4 and week 12 after cancer theraphy

  • Concentration of plasma albumin change among before, during and after cancer therapy

    assessing the change of plasma albumin concentration among week 0, week 4 and week 12

    week 0 , week 4 and week 12 after cancer theraphy

  • Concentration of plasma myostatin change among before, during and after cancer therapy

    assessing the change of plasma myostatin concentration among week 0, week 4 and week 12

    week 0 , week 4 and week 12 after cancer theraphy

  • Concentration of plasma FSTL-1 change among before, during and after cancer therapy

    assessing the change of plasma FSTL-1 concentration among week 0, week 4 and week 12

    week 0 , week 4 and week 12 after cancer theraphy

  • Concentration of plasma IL-6 change among before, during and aftercancer therapy

    assessing the change of plasma IL-6 concentration among week 0, week 4 and week 12

    week 0 , week 4 and week 12 after cancer theraphy

  • Concentration of plasma irisin change among before, during and after cancer therapy

    assessing the change of plasma irisin concentration among week 0, week 4 and week 12

    week 0 , week 4 and week 12 after cancer theraphy

  • Concentration of plasma adiponectin change among before, during and after cancer therapy

    assessing the change of plasma adiponectin concentration among week 0, week 4 and week 12

    week 0 , week 4 and week 12 after cancer theraphy

  • Concentration of plasma MCP-1 change among before, during and after cancer therapy

    assessing the change of plasma MCP-1 concentration among week 0, week 4 and week 12

    week 0 , week 4 and week 12 after cancer theraphy

  • Concentration of plasma aquaporin change among before, during and after cancer therapy

    assessing the change of plasma aquaporin concentration among week 0, week 4 and week 12

    week 0 , week 4 and week 12 after cancer theraphy

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who diagnosed with lung cancer including small cell and non-small cell lung cancer from 2023-03-1to 2026-02-28 will be eligible for the study. Every patients' performance status must be in 0-2 and can receive any cancer treatments including chemotherapy.

You may qualify if:

  • Diagnosis of lung cancer stage III to stage IV
  • Adults over 20 years old
  • Daily performance status of 0- 2

You may not qualify if:

  • \. Cardiac stents or pacemakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Adipo-myokines concentrations will be checked using residual plasma specimens on the date of before therapy, 4 weeks after therapy and 12 weeks after therapy

Study Officials

  • TSENG CHIA-CHENG

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2023

First Posted

September 29, 2023

Study Start

February 2, 2023

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations