Clinical trial · Observational
"Cancersensor": Circadian Rhythms
Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring of Cancer Therapy : the Circadian Rhythms of Urinary Excretion of Modified Nucleosides.
NCT01693835CI-TRIAL-00097341completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Patients
- description
- Patients with metastatic colorectal cancer
- label
- Healthy subjects
- description
- Age and sec-matched healthy subjects
Primary outcomes (1)
- measure
- Circadian rhythms in urinary excretion of modified nucleosides
- timeFrame
- 2 days repeated measures
- description
- 10 Urine samples over 2 days Measurement of modified nucleosides, cortisol and 6-sulfatoxymelatonin concentration 1 saliva sample Measurement of Clock genes polymorphisms expression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTDulong 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. PMID 34907230