"Cancersensor": Circadian Rhythms

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

Status: Completed

Conditions: Metastatic Colorectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01693835

C11-42

2012-A00010-43 (Registry Identifier)

Details and patient eligibility

About

Observational, non randomized study aimed at measuring the circadian rhythms in the urinary concentrations of physiological modified nucleosides in 30 patients with metastatic colorectal cancer and in 30 age and sex-matched healthy subjects.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for patients:

• 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.

Inclusion criteria for healthy subject

• Age ≥ 18 ans
• Signed informed consent;
• Good understanding of the protocol and of the follow-up;
• Good haematological, hepatic and renal functions.
• Test HIV and B and C hepatitis negative test
• No chronic or acute diseases

Exclusion Criteria for patients:

• Poor performance status (>2);
• 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.

Exclusion criteria for healthy subject:

• 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

32 participants in 2 patient groups

Patients

Description:

Patients with metastatic colorectal cancer

Healthy subjects

Description:

Age and sec-matched healthy subjects