Cohort Study of Patients With Hepatocellular Carcinoma and Circulating Tumor DNA Monitoring of Chemoembolization

NCT05390112 | Unknown DMC

• 1 other identifier: 2019/330/OB
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

Cohort study to assess the impact of ctDNA detection in the follow-up and management of patients with hepatocellular carcinoma treated by TACE

Conditions

Circulating Tumor DNA; Hepatocellular Carcinoma Non-resectable; Transarterial Chemoembolization

Keywords

cell-free DNA; circulating tumor DNA; hepatocellular carcinoma;

Outcome Measures

Primary Outcomes (1)

• Radiological response at 1 month according to mRECIST and ctDNA detection

  radiological response : mRECIST (progressive disease; stable disease, partial response, complete response) LIRADS (LR-TR Nonviable, LR-TR Equivocal, LR-TR Viable); ctDNA at 1 month detection (yes or no)

  4 to 6 weeks

Secondary Outcomes (1)

• Progression-free survival and overall survival

  4 to 6 weeks

Interventions

DNA BIOLOGICAL

ctDNA; cfDNA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Patient with a first TACE (naive) or not, regardless of the number of previous procedures * Patient naïve or on a new line of oncological treatment, regardless of the number of previous lines of treatment.

You may qualify if:

• Age ≥ 18 years
• HCC diagnosed on consensus radiological criteria in cirrhotic patients (EASL-EORTC 2012): helical CT or MRI with triple arterial, portal, and late acquisition. The diagnosis is based on the presence of hypervascularization at the early arterial time (wash-in) with wash-out (hypodensity or hypointensity compared with non-tumor liver parenchyma) at the portal phase or late phase compared with non-tumor parenchyma.
• Histologically diagnosed HCC in the absence of an imaging diagnosis
• Patient with a first TACE (naive) or not, regardless of the number of previous procedures
• Patient naïve or on a new line of oncological treatment, regardless of the number of previous lines of treatment.
• Treatment decision validated by the digestive oncology staff.
• Patient having read and understood the information letter and signed the informed consent.
• Patient follow-up performed at the Charles Nicolle University Hospital in Rouen.

You may not qualify if:

• Other active cancer or hematological malignancy, currently being treated
• Patient not affiliated to the social security system
• Pregnant woman or woman in labour or breastfeeding
• Person deprived of liberty by an administrative or judicial decision
• Person placed under court protection

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

CHU de Rouen

Rouen, 76031, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

cfDNA ; ctDNA

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

DNA

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Vincent VERDIER, MD

  vincent.verdier@chu-rouen.fr

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent VERDIER, MD

CONTACT

+33 2 32 88 86 10; vincent.verdier@chu-rouen.fr

Study Design

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

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 25, 2022
• Study Start: May 20, 2021
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)