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NCT Number: NCT06314997

Dynamic Changes in Circulating Tumour Cells Protein Expression

This multicenter study, randomized, controlled of blood-based biomarker-driven targhet therapy. Patients were selectedm( at Hospital San Giovanni and Celio in Rome) according to CTCs results ( CTCs-guided managment performed at University Magna Graecia) or managed by the treating clinician according to standard pathological criteria (standard management). The participants were assigned to trial groups with the use of block randomization stratified according to the enrolling center location metropolitan) and tumor stage (T3 or T4).

Recruiting

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Key information

Conditions

Objective Responsive Rate (ORR)

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Natalia Malara

Germaneto, Italy, 88100

Location status: Recruiting

About this study

The investigators enroll patients with histologically confirmed advanced stage (T3 or T4, N1/2, M0/1) colorectal adenocarcinoma with molecular analysis on RAS mutant status. The participants are enrolled within 3 weeks at the time of progression disease (PD) from any line of therapy. Blood samples were collected from each participant after obtaining informed consent. Permission to perform CTCs analysis from blood was obtained from the Regional Ethical Committee (No.2013/34) and the study is conducted in accordance with the Declaration of Helsinki.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 to 2 (scores range from 0 to 5, with higher numbers reflecting greater disability) ,
  • medically able to receive chemotherapy.

Exclusion criteria

  • evidence of infective disease before enrollment ,
  • a history of another primary cancer within the previous 3 years,
  • the presence of synchronous primary colorectal cancer.

Treatment and study plan

panitumumab (EGFR inhibitors)

Drug

Chemotherapy treatment includes anti-EGFR biologics such as cetuximab or panitumumab, antiangiogenic drugs such as bevacizumab or aflibercept. The indication to treat depends from the presence of CTCs analysed for Ras mutation and HER2 expression

Primary outcomes

  1. The primary efficacy end point was Objective Responsive Rate (ORR) at 12 months.

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Natalia Malara

CONTACT

[email protected]

Natalia Malara, prof

CONTACT

[email protected]

03489705145

Sponsors and collaborators

Lead sponsor

Matteo's Friends

Other

Registry information

Official study title

Dynamic Changes in RAS Gene Status and HER2 Expression in Circulating Tumour Cells: a Phase II Trial

Acronym: Liquid-DRER2

Important dates

Study start
2019
Primary completion
2024
Study completion
2027
First posted
Mar 18, 2024
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.