NCT05223608

Brief Summary

ImmuCCo-1905 is a monocentric interventional study on patients treated by immunotherapy, which consist in establishment of a prospective clinic-biologic database over 5 years, associated with a biobank. This database will allow carrying out works aiming at assessing immunotherapy in real life situation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
651

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress70%
Mar 2022Mar 2028

First Submitted

Initial submission to the registry

January 24, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

March 3, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

January 24, 2022

Last Update Submit

March 25, 2026

Conditions

Solid Tumor, Adult

Keywords

Prospective cohortClinic-biologic databaseSolid tumorImmunotherapy

Outcome Measures

Primary Outcomes (1)

  • Number of patients treated by immunotherapy and registered in the database.

    Number of patients treated by immunotherapy and registered in the database

    5 years

Secondary Outcomes (5)

  • Overall Survival

    6 years

  • Progression-Free Survival

    6 years

  • Tumor response

    6 years

  • Co-medications

    6 years

  • Toxicity of immunotherapy

    6 years

Study Arms (1)

ImmuCCo Cohort

OTHER

Blood sampling at initiation of immunotherapy, at the first tumor assessment, in case of severe toxicity. Urine collection at initiation of immunotherapy.

Other: ImmuCCo Cohort

Interventions

ImmuCCo CohortOTHER

Blood sampling at initiation of immunotherapy, at the first tumor assessment, in case of severe toxicity. Urine collection at initiation of immunotherapy.

ImmuCCo Cohort

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • Beginning a first immunotherapy by immune checkpoint inhibitor - anti-PD1 (Programmed cell Death protein-1), anti-PDL1 (Programmed cell Death protein-1 ligand), anti-CTLA4 (Cytotoxic T-Lymphocyte associated protein 4), as monotherapy or in combination, in the Centre Oscar Lambret (COL)
  • In neo-adjuvant, adjuvant, recurrence or metastatic situation
  • Suffering from solid tumor histologically documented
  • Signed written informed consent

You may not qualify if:

  • Pregnant or breastfeeding women
  • Patient already treated by immunotherapy by immune checkpoint inhibitor
  • Person under guardianship
  • Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar Lambret

Lille, Hauts-de-France, 59, France

RECRUITING

Study Officials

  • Alexandra FORESTIER, MD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien THERY

CONTACT

+330320295918promotion@o-lambret.fr

Marjane BELMIMOUN

CONTACT

+330320295918promotion@o-lambret.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Observational study model with additional blood samples and urine collection
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2022

First Posted

February 4, 2022

Study Start

March 3, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

FR(1)