NCT05988970

Brief Summary

This is a prospective pilot study designed to demonstrate the impact of circadian rhythm on the spread of Circulating Tumor Cells (CTCs) in patients with Non- Small Cell Lung Cancer - NSCLC. 27 patients will be included in the study and will be followed for 12 months. For each included patient, blood samples will be collected before the anticancer treatment initiation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

2 active sites

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

August 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

January 29, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2026

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

August 3, 2023

Last Update Submit

January 23, 2026

Conditions

Lung Cancer

Keywords

Circadian rhythmCirculating tumor cellsCTCCellSearchParSortix

Outcome Measures

Primary Outcomes (1)

  • Presence of CTCs detected with the CellSearch technique.

    12 months after the end of inclusions

Secondary Outcomes (4)

  • Quantification of CTCs by the CellSearch technique and expressed in number of cells / millilitre of blood.

    12 months after the end of inclusions

  • Quantification of CTCs by the ParSortix technique and expressed in number of cells / millilitre of blood.

    12 months after the end of inclusions

  • Objective response defined as complete or partial response.

    12 months after the end of inclusions

  • Progression-free survival (PFS) defined as the time between the date of inclusion and the date of first progression or death.

    12 months after the end of inclusions

Study Arms (1)

Patients with Non- Small Cell Lung Cancer - NSCLC

OTHER
Other: Blood samples will be collected at two times before the treatment initiation:

Interventions

Blood samples will be collected at two times before the treatment initiation:OTHER

* at 4:00 a.m. * at 10:00 a.m. Patients will then be followed for data collection for a period of 12 months after inclusion or until disease progression (if applicable).

Patients with Non- Small Cell Lung Cancer - NSCLC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with histologically confirmed advanced NSCLC (inoperable stage 3 or 4)
  • Patient aged ≥ 18 years
  • Life expectancy \> 3 months
  • Patient naïve to treatment for NSCLC
  • Patient hospitalized at least one night for initiation of specific treatment (chemotherapy, radiotherapy, surgery, other...)
  • Patient with no other active cancer. Cancer history accepted if more than 3 years old and considered cured.
  • Patient affiliated to a Social Security scheme in France.

You may not qualify if:

  • Small-cell cancer or cancer with a majority small-cell contingent
  • Patient previously treated for NSCLC
  • Outpatient
  • Patient with active pathology such as sepsis or uncontrolled inflammatory syndrome
  • Any pathology contraindicating the sample collection procedures required by the study.
  • Pregnant or breast-feeding women.
  • Any psychological, family, geographical or sociological condition that makes it impossible to comply with the medical follow-up and/or procedures stipulated in the study protocol.
  • Patients deprived of their liberty or under legal protection (guardianship, legal protection).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Larrey

Toulouse, France

Location

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, France

Location

MeSH Terms

Conditions

Lung NeoplasmsNeoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 14, 2023

Study Start

January 29, 2024

Primary Completion

January 21, 2026

Study Completion

January 21, 2026

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations

FR(2)