"Cancersensor" Metastasis Resection

Institut National de la Santé Et de la Recherche Médicale, France

Status: Completed

Conditions: Metastatic Colorectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01693848

C11-58

2012-A00011-42 (Registry Identifier)

Details and patient eligibility

About

Observational, non randomized study aimed at measuring the effect of surgical resection of metastasis in the urinary concentrations of physiological modified nucleosides in 45 patients with metastatic colorectal cancer.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically-confirmed metastatic colorectal cancer;
• 0 to 3 prior chemotherapy lines; Signed informed consent;
• Good understanding of the protocol and of the follow-up;
• Estimated life expectancy exceeding 3 months;
• At least one measurable metastatic lesion (RECIST criteria);
• Performance Status (WHO) of 0 to 2;
• Good haematological, hepatic and renal functions.

Exclusion criteria

• Poor haematological, hepatic or renal functions;
• Uncontrolled chronic disease;
• Serious unhealed wound, ulcer or fracture within the previous month;
• Clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion;
• Pregnancy or breast-feeding during the previous month;
• Transmeridian trip of more than 4 time zones within the prior 2 weeks;
• Person with legal restriction to participate into clinical research, according to the current law in France.

Trial design

10 participants in 2 patient groups

Patients

Description:

Patients with metastatic colorectal cancer scheduled for metastatic surgery

Control patients

Description:

Patients with metastatic colorectal cancer scheduled for general anesthesia without metastatic surgery