Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-03-01 @ 9:55 PM
Study NCT ID:
NCT02495532
Status:
UNKNOWN
Last Update Posted:
2015-07-13
First Post:
2015-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial Comparing Carnoy's and GEWF Solutions for Lymph Node Clearing Technique in Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal 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': 'D009369', 'term': 'Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C046544', 'term': 'methacarn'}, {'id': 'C000707730', 'term': 'gewf solution'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-08', 'studyFirstSubmitDate': '2015-04-16', 'studyFirstSubmitQcDate': '2015-07-08', 'lastUpdatePostDateStruct': {'date': '2015-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lymph nodes harvested', 'timeFrame': 'One week', 'description': 'Number of additional lymph nodes harvested with the clearing technique'}], 'secondaryOutcomes': [{'measure': 'Lymph node metastasis', 'timeFrame': 'One week', 'description': 'Presence of metastasis in the additional lymph nodes harvested'}, {'measure': 'Upstage of lymph nodes', 'timeFrame': 'One week', 'description': 'Diagnosis of lymph node metastasis in a patient initially classified as having no lymph node metastasis or increase in the number of metastatic lymph nodes in a patient already staged as having lymph node metastasis.'}, {'measure': 'Adjuvant therapy', 'timeFrame': 'One month', 'description': 'Indication of adjuvant therapy as consequence of the upstaging after the lymph nodes clearing technique.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neoplasm Metastasis', 'Colorectal Neoplasms', 'Lymph Nodes', 'Lymph Node Revealing Solution'], 'conditions': ['Colorectal Neoplasms', 'Neoplasm Metastasis']}, 'descriptionModule': {'briefSummary': 'Regional lymph node metastasis is a major determinant of local recurrence and overall survival rates in patients with colorectal cancer. Because of the poor prognosis associated with the presence of lymph node metastasis, stage III colorectal cancer patients should receive adjuvant treatment with chemo and / or radiation therapy according to the site of tumor. Several authors have investigated the use of revealing solutions for lymph node clearance in colorectal cancer. Most studies comparing conventional histopathological specimen examination to any lymph node clearing technique showed that the use of revealing solutions increases the mean number of lymph nodes harvested, usually in a statistically significant manner. It is still controversial the impact of the use of revealing solutions for upstaging of lymph node status and consequently for the indication for adjuvant therapy. Therefore will be conducted a randomized clinical trial to compares the performance of GEWF and Carnoy solutions for the histopathological examination of patients with colorectal cancer. The aim of this study is to determine the lymph node revealing solution with the best performance (increase in the mean number of lymph node harvested and lymph node upstaging) in patients with colorectal cancer.', 'detailedDescription': 'Patients with histologically proven colorectal adenocarcinoma submitted to curative resection and conventional histopathological examination of the surgical specimen are randomized to undergo further investigation by lymph node clearing technique with Carnoy or GEWF solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven colorectal adenocarcinoma\n* Voluntary agreement of the patient to participate in research\n* Voluntary agreement of the surgeon to participate in research\n\nExclusion Criteria:\n\n* Absence of accurate histopathological data'}, 'identificationModule': {'nctId': 'NCT02495532', 'briefTitle': "Clinical Trial Comparing Carnoy's and GEWF Solutions for Lymph Node Clearing Technique in Colorectal Cancer", 'organization': {'class': 'OTHER', 'fullName': 'Hospital Moinhos de Vento'}, 'officialTitle': "Randomized Clinical Trial Comparing Carnoy's and GEWF Solutions for Lymph Node Clearing Technique in Colorectal Cancer", 'orgStudyIdInfo': {'id': '39919814.7.0000.5330'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Colon Cancer', 'description': 'The subjects in this group will undergo intervention by having surgery and lymph node clearing technique.\n\nIntervention A: Carnoy solution Intervention B: GEWF solution', 'interventionNames': ['Other: Lymph node clearing technique with Carnoy solution', 'Other: Lymph node clearing technique with GEWF solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rectal Cancer', 'description': 'The subjects in this group will undergo intervention by having surgery and lymph node clearing technique.\n\nIntervention A: Carnoy solution Intervention B: GEWF solution', 'interventionNames': ['Other: Lymph node clearing technique with Carnoy solution', 'Other: Lymph node clearing technique with GEWF solution']}], 'interventions': [{'name': 'Lymph node clearing technique with Carnoy solution', 'type': 'OTHER', 'otherNames': ['Carnoy'], 'description': 'Procedure: lymph node clearing technique with Carnoy solution\n\n(1) just after the surgical resection each specimen is fixed by formaldehyde; (2) lymph node harvesting is performed by a manual technique of vision and palpation; (3) lymph nodes retrieved are counted, stained with hematoxylin and eosin and examined with light microscopy; (4) the surgical specimen is submitted to re-fixation with Carnoy solution and another lymph node harvesting by manual technique of vision and palpation; (5) additional lymph nodes retrieved are counted, stained with hematoxylin and eosin and examined with light microscopy.', 'armGroupLabels': ['Colon Cancer', 'Rectal Cancer']}, {'name': 'Lymph node clearing technique with GEWF solution', 'type': 'OTHER', 'otherNames': ['GEWF'], 'description': 'Procedure: lymph node clearing technique with GEWF solution\n\n(1) just after the surgical resection each specimen is fixed by formaldehyde; (2) lymph node harvesting is performed by a manual technique of vision and palpation; (3) lymph nodes retrieved are counted, stained with hematoxylin and eosin and examined with light microscopy; (4) the surgical specimen is submitted to re-fixation with GEWF solution and another lymph node harvesting by manual technique of vision and palpation; (5) additional lymph nodes retrieved are counted, stained with hematoxylin and eosin and examined with light microscopy.', 'armGroupLabels': ['Colon Cancer', 'Rectal Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035001', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Tiago L Ghezzi, MD, PhD', 'role': 'CONTACT', 'email': 'tlghezzi@terra.com.br', 'phone': '+ 555197256265'}], 'facility': 'Hospital Moinhos de Vento', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Tiago L Ghezzi, MD, PhD', 'role': 'CONTACT', 'email': 'tlghezzi@terra.com.br', 'phone': '+ 555197256265'}], 'overallOfficials': [{'name': 'Antonio N Kalil, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Researcher'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Moinhos de Vento', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federal University of Health Science of Porto Alegre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}