"Cancersensor": Circadian Rhythms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Keywords

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Colorectal Cancer Metastatic Healthy Control Circadian Urine Nucleosides

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients with metastatic colorectal cancer

No interventions assigned to this group

Healthy subjects

Age and sec-matched healthy subjects

No interventions assigned to this group

Eligibility Criteria

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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.

* 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

* 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.

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francis Lévi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

INSERM and AP-HP and Paris South University

Sandrine Dulong, PhD

Role: STUDY_DIRECTOR

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

Locations

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Paul Brousse Hospital

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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2012-A00010-43

Identifier Type: REGISTRY

Identifier Source: secondary_id

C11-42

Identifier Type: -

Identifier Source: org_study_id