NCT04879316

Brief Summary

CERTIM is a cohort created in July 2015 to set up a multidisciplinary follow-up of cancer patients treated with immune checkpoint inhibitors. From the CERTIM cohort, we conducted a longitudinal, prospective, observational study (ELY) in two tertiary university centers (Cochin hospital and European Georges Pompidou Hospital), which included patients between August 2016 and October 2019 and ended follow-up in April 2020. Patients were treated with nivolumab, at a dose of 3 mg/kg every 2 weeks, or pembrolizumab, at a dose of 2mg/kg every 3 weeks. The investigators report findings from an evaluation of rest energy expenditure (REE) assessed using indirect calorimetry in the outpatient setting before treatment with checkpoints inhibitors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

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

Study Start

First participant enrolled

August 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

3.2 years

First QC Date

April 12, 2021

Last Update Submit

May 10, 2021

Conditions

Non-small Cell Lung CancerProgression, Disease

Keywords

cachexiaimmunotherapycarcinomaNon-small cell lung cancerBasal metabolismEnergy expenditureinflammation6-month Progression free survival

Outcome Measures

Primary Outcomes (1)

  • 6-month Progression-free survival

    Calculated as the percentage of participants alive and without disease progression, as assessed by the Investigator using RECIST v1.1

    6 months after start of treatment

Study Arms (1)

adult patients with NSCLC initiating nivolumab or pembrolizumab

Patients underwent a multidisciplinary evaluation including consultation with an oncologist and a dietitian. Such an assessment includes subjective and objective parameters such as medical history, weight loss, current dietary intake (including energy and protein balance), physical examination and anthropometric measurements, functional and mental assessment, medications, Resting Energy Expenditure measurement using indirect calorimetry and laboratory values.

Other: Resting Energy Expenditure measurement

Interventions

Resting Energy Expenditure measurementOTHER

Resting Energy Expenditure measurement using indirect calorimetry

adult patients with NSCLC initiating nivolumab or pembrolizumab

Eligibility Criteria

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

Adult patients with NSCLC initiating nivolumab or pembrolizumab in real-life conditions

You may qualify if:

  • years or older
  • Stage IV histologically proven Non Small Cell Lung Cancer (NSCLC)
  • Monotherapy with nivolumab or pembrolizumab.
  • Patients were required to have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

You may not qualify if:

  • Active malignancy other than NSCLC,
  • ALK or EGFR mutated NSCLC
  • Anticancer therapy or surgery within the past 2 weeks or inability to breathe under the calorimetry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, 75014, France

Location

Related Publications (1)

  • Montegut L, Joseph A, Chen H, Abdellatif M, Ruckenstuhl C, Motino O, Lambertucci F, Anagnostopoulos G, Lachkar S, Dichtinger S, Maiuri MC, Goldwasser F, Blanchet B, Fumeron F, Martins I, Madeo F, Kroemer G. High plasma concentrations of acyl-coenzyme A binding protein (ACBP) predispose to cardiovascular disease: Evidence for a phylogenetically conserved proaging function of ACBP. Aging Cell. 2023 Jan;22(1):e13751. doi: 10.1111/acel.13751. Epub 2022 Dec 12.

    PMID: 36510662DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungDisease ProgressionCachexiaCarcinomaInflammation

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightSigns and SymptomsThinnessNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-investigator

Study Record Dates

First Submitted

April 12, 2021

First Posted

May 10, 2021

Study Start

August 1, 2016

Primary Completion

October 1, 2019

Study Completion

April 30, 2020

Last Updated

May 12, 2021

Record last verified: 2021-05

Locations

FR(1)