Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT01693835
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2012-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"Cancersensor": Circadian Rhythms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva (exfoliated oral mucosa cells) and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2012-09-07', 'studyFirstSubmitQcDate': '2012-09-24', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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\n\n1 saliva sample Measurement of Clock genes polymorphisms expression'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colorectal', 'Cancer', 'Metastatic', 'Healthy', 'Control', 'Circadian', 'Urine', 'Nucleosides'], 'conditions': ['Metastatic Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '34907230', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with metastatic colorectal cancer treated at the Department of Medical Oncology of Paul Brousse Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for patients:\n\n* Histologically-confirmed metastatic colorectal cancer;\n* 0 to 3 prior chemotherapy lines;\n* Signed informed consent;\n* Good understanding of the protocol and of the follow-up;\n* Estimated life expectancy exceeding 3 months;\n* At least one measurable metastatic lesion (RECIST criteria);\n* Performance Status (WHO) of 0 to 2;\n* Good haematological, hepatic and renal functions.\n\nInclusion criteria for healthy subject\n\n* Age ≥ 18 ans\n* Signed informed consent;\n* Good understanding of the protocol and of the follow-up;\n* Good haematological, hepatic and renal functions.\n* Test HIV and B and C hepatitis negative test\n* No chronic or acute diseases\n\nExclusion Criteria for patients:\n\n* Poor performance status (\\>2);\n* Poor haematological, hepatic or renal functions;\n* Uncontrolled chronic disease;\n* Serious unhealed wound, ulcer or fracture within the previous month;\n* Clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion;\n* Pregnancy or breast-feeding during the previous month;\n* Transmeridian trip of more than 4 time zones within the prior 2 weeks;\n* Person with legal restriction to participate into clinical research, according to the current law in France.\n\nExclusion criteria for healthy subject:\n\n* Poor haematological, hepatic or renal functions;\n* Uncontrolled chronic disease;\n* Serious unhealed wound, ulcer or fracture within the previous month;\n* Clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion;\n* Pregnancy or breast-feeding during the previous month;\n* Transmeridian trip of more than 4 time zones within the prior 2 weeks;\n* Person with legal restriction to participate into clinical research, according to the current law in France.'}, 'identificationModule': {'nctId': 'NCT01693835', 'briefTitle': '"Cancersensor": Circadian Rhythms', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': 'Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring of Cancer Therapy : the Circadian Rhythms of Urinary Excretion of Modified Nucleosides.', 'orgStudyIdInfo': {'id': 'C11-42'}, 'secondaryIdInfos': [{'id': '2012-A00010-43', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients with metastatic colorectal cancer'}, {'label': 'Healthy subjects', 'description': 'Age and sec-matched healthy subjects'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Paul Brousse Hospital', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Francis Lévi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INSERM and AP-HP and Paris South University'}, {'name': 'Sandrine Dulong, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut National de la Santé Et de la Recherche Médicale, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}