NCT05103969 is a clinical trial in Tumors, sponsored by Federation Francophone de Cancerologie Digestive.

Who is sponsoring NCT05103969?

NCT05103969 is sponsored by Federation Francophone de Cancerologie Digestive.

What condition does NCT05103969 study?

NCT05103969 studies Tumors, POLE Exonuclease Domain Mutation, POLD1 Gene Mutation.

Is NCT05103969 still recruiting?

NCT05103969 is currently recruiting now. Last updated 8 July 2024.

Last reviewed 2024-07-08 · How we verify

NCT05103969

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Cohort of Tumors With POLE/D1 Mutation

Recruiting now Last updated 8 July 2024

What this trial tests

trial in Tumors in 100 participants. Currently enrolling.

Timeline

5 October 2021

Primary endpoint
6 October 2025

6 October 2025

Quick facts

Lead sponsor	Federation Francophone de Cancerologie Digestive
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	100
Start date	5 October 2021
Primary completion	6 October 2025
Estimated completion	6 October 2025
Sites	1 location across France

Conditions studied

Tumors — all drugs for Tumors →
POLE Exonuclease Domain Mutation — all drugs for POLE Exonuclease Domain Mutation →
POLD1 Gene Mutation — all drugs for POLD1 Gene Mutation →

Sponsor

Federation Francophone de Cancerologie Digestive — full company profile →

Who can join

18 and older, any sex, with Tumors or POLE Exonuclease Domain Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary objective of this study is to identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE (Polymerase ɛ)/POLD1 mutation identified by molecular biology platforms for all stages and primary sites combined

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

POLE/POLD1 mutation and tumor immunotherapy.
Ma X, Dong L, Liu X, Ou K, et al · · 2022 · cited 90× · PMID 35780178 · DOI 10.1186/s13046-022-02422-1
Prospects of POLD1 in Human Cancers: A Review.
Gola M, Stefaniak P, Godlewski J, Jereczek-Fossa BA, et al · · 2023 · cited 17× · PMID 36980791 · DOI 10.3390/cancers15061905
Beyond proofreading: POLD1 mutations as dynamic orchestrators of genomic instability and immune evasion in cancer.
Chen H, Wei J, Tang Q, Li G, et al · · 2025 · cited 3× · PMID 40661943 · DOI 10.3389/fimmu.2025.1600233
Optimizing early-phase immunotherapy trials: the role of biomarker enrichment strategies.
Catani G, Morchón-Araujo D, Mirallas O, Sánchez-Pérez V, et al · · 2025 · cited 2× · PMID 41200168 · DOI 10.3389/fimmu.2025.1664443
Screening, Prognostic, and Predictive Molecular Tools for Colorectal Cancer: Recent Advances in the Classical Background
Pavalean M, Lambrescu I, Pavalean M, Gaina G, et al · · 2026

Verify or expand the search:

Other recruiting trials for Tumors

Currently open trials in the same condition.

NCT05697406 — HP Pyruvate MRI in Cancers · Phase 1, PHASE2 · recruiting
NCT05103358 — Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 G · Phase 2 · active not recruiting
NCT04950959 — XACT ACE Observational Registry · recruiting
NCT04341181 — ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling · Phase 2 · recruiting
NCT05733091 — Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base Tumors · recruiting

Other Federation Francophone de Cancerologie Digestive trials

Trials by the same sponsor.

NCT07124858 — Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metast · NA · not yet recruiting
NCT07150403 — Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) P · Phase 2 · not yet recruiting
NCT07270991 — Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma · Phase 3 · recruiting
NCT07128290 — PErioperative CISGEM + Rilvegostomig in High-Risk Resectable Intra Hepatic CholangioCarcinoma · Phase 2 · not yet recruiting
NCT07124884 — 5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non- · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05103969 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Federation Francophone de Cancerologie Digestive
Last refreshed: 8 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05103969.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing