"Cancersensor" Chemotherapy
This study is currently recruiting participants.
Verified September 2012 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01693861
First received: September 7, 2012
Last updated: September 24, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Observational, non randomized study aimed at measuring the effect of chemotherapy in the urinary concentrations of physiological modified nucleosides in 30 patients with metastatic colorectal cancer.
| Condition |
|---|
|
Metastatic Colorectal Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring of Cancer Therapy : Effect of Chemotherapy on Cancerous Proliferation Based on the Dynamic Excretion of Urinary Nucleosides. |
Resource links provided by NLM:
Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:
Primary Outcome Measures:
- Effect of chemotherapy on urinary excretion of modified nucleosides [ Time Frame: 17 days ] [ Designated as safety issue: No ]
1 urine sample per day 3 days before and 14 days after beginning of chemotherapy Measurement of modified nucleosides, cortisol and 6-sulfatoxymelatonin concentration
1 saliva sample : Measurement of Clock genes polymorphisms expression
Other Outcome Measures:
- Identification of modified nucleosides as biomarkers for colorectal cancer [ Time Frame: 17 days ] [ Designated as safety issue: No ]
Measurement of modified nucleosides, cortisol and 6-sulfatoxymelatonin concentration in urine samples before and after chemotherapy
1 saliva sample Measurement of Clock genes polymorphisms expression
Biospecimen Retention: Samples With DNA
Urine and exfoliated oral mucosa cells
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Patients
Patients with metastatic colorectal cancer treated with chemotherapy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with metastatic colorectal cancer treated at the Department of Medical Oncology of Paul Brousse Hospital
Criteria
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:
- More than 2 surgical resections of metastases from colorectal cancer;
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693861
Contacts
| Contact: Francis Lévi, MD PhD | +33145593595 | francis.levi@inserm.fr |
| Contact: Sandrine Dulong, PhD | +33149583479 | sandrine.dulong@inserm.fr |
Locations
| France | |
| Paul Brousse Hospital | Recruiting |
| Villejuif, France, 94807 | |
| Contact: Sandrine Dulong, PhD +33149583479 sandrine.dulong@inserm.fr | |
| Contact: Abdoulaye Karaboué, MD +33145593553 abdoulaye.karaboue@inserm.fr | |
| Principal Investigator: Francis Lévi, MD PhD | |
| Sub-Investigator: Pasquale Innominato, MD | |
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
| Principal Investigator: | Francis Lévi, MD PhD | INSERM CNRS AP-HP Université Paris Sud |
More Information
No publications provided
| Responsible Party: | Institut National de la Santé Et de la Recherche Médicale, France |
| ClinicalTrials.gov Identifier: | NCT01693861 History of Changes |
| Other Study ID Numbers: | C11-59, 2012-A00168-35 |
| Study First Received: | September 7, 2012 |
| Last Updated: | September 24, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
|
Colorectal Cancer Metastatic Chronotherapy |
Urine Nucleosides Chemotherapy Treated with chemotherapy |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013