"Cancersensor": Circadian Rhythms | NCT01693835

Studies
"Cancersensor": Circadian Rhythms

NCT01693835

Sponsor

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

Status

Completed

Last Update Posted

Nov 18, 2025Actual

Enrollment

32Actual

Phase

Not provided

Conditions

Metastatic Colorectal Cancer

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2012-A00010-43	Registry Identifier	IDRCB

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Sep 7, 2012

First Submission Date that Met QC Criteria

Sep 24, 2012

First Posted Date

Sep 26, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2025

Last Update Posted Date

Nov 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

32Actual

Label	Type	Description	Intervention Names
Patients		Patients with metastatic colorectal cancer
Healthy subjects		Age and sec-matched healthy subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Circadian rhythms in urinary excretion of modified nucleosides	10 Urine samples over 2 days Measurement of modified nucleosides, cortisol and 6-sulfatoxymelatonin concentration 1 saliva sample Measurement of Clock genes polymorphisms expression	2 days repeated measures

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with metastatic colorectal cancer treated at the Department of Medical Oncology of Paul Brousse Hospital

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Francis Lévi, MD, PhD	INSERM and AP-HP and Paris South University	Principal Investigator
Sandrine Dulong, PhD	Institut National de la Santé Et de la Recherche Médicale, France	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Paul Brousse Hospital		Villejuif		94800	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34907230	Result	Dulong S, Huang Q, Innominato PF, Karaboue A, Bouchahda M, Pruvost A, Theodoro F, Agrofoglio LA, Adam R, Finkenstadt B, Levi F. Circadian and chemotherapy-related changes in urinary modified nucleosides excretion in patients with metastatic colorectal cancer. Sci Rep. 2021 Dec 14;11(1):24015. doi: 10.1038/s41598-021-03247-2.

ID	Term
D015179	Colorectal Neoplasms
D009369	Neoplasms
D009362	Neoplasm Metastasis

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site