Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:13 PM
Study NCT ID:
NCT06096493
Status:
UNKNOWN
Last Update Posted:
2023-10-23
First Post:
2023-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Factors Affecting Recurrence and Disease-Free Survival After Surgical Resection for Cancer Rectum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-21', 'studyFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2023-10-21', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor recurrence', 'timeFrame': 'Through study completion, an average of 3 year', 'description': 'Presence of Tumor recurrence after curative surgery for cancer rectum.'}, {'measure': 'Disease free survival.', 'timeFrame': 'up to 5 years', 'description': 'From date of surgery until the date of recurrence detection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer rectum', 'recurrence', 'disease free survival'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '29950897', 'type': 'BACKGROUND', 'citation': 'He WZ, Xie QK, Hu WM, Kong PF, Yang L, Yang YZ, Jiang C, Yin CX, Qiu HJ, Zhang HZ, Zhang B, Xia LP. An increased number of negative lymph nodes is associated with a higher immune response and longer survival in colon cancer patients. Cancer Manag Res. 2018 Jun 18;10:1597-1604. doi: 10.2147/CMAR.S160100. eCollection 2018.'}, {'pmid': '24587671', 'type': 'BACKGROUND', 'citation': 'Li Destri G, Di Carlo I, Scilletta R, Scilletta B, Puleo S. Colorectal cancer and lymph nodes: the obsession with the number 12. World J Gastroenterol. 2014 Feb 28;20(8):1951-60. doi: 10.3748/wjg.v20.i8.1951.'}, {'pmid': '31203527', 'type': 'BACKGROUND', 'citation': 'Hashiguchi Y, Muro K, Saito Y, Ito Y, Ajioka Y, Hamaguchi T, Hasegawa K, Hotta K, Ishida H, Ishiguro M, Ishihara S, Kanemitsu Y, Kinugasa Y, Murofushi K, Nakajima TE, Oka S, Tanaka T, Taniguchi H, Tsuji A, Uehara K, Ueno H, Yamanaka T, Yamazaki K, Yoshida M, Yoshino T, Itabashi M, Sakamaki K, Sano K, Shimada Y, Tanaka S, Uetake H, Yamaguchi S, Yamaguchi N, Kobayashi H, Matsuda K, Kotake K, Sugihara K; Japanese Society for Cancer of the Colon and Rectum. Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2019 for the treatment of colorectal cancer. Int J Clin Oncol. 2020 Jan;25(1):1-42. doi: 10.1007/s10147-019-01485-z. Epub 2019 Jun 15.'}, {'pmid': '6751457', 'type': 'BACKGROUND', 'citation': 'Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery--the clue to pelvic recurrence? Br J Surg. 1982 Oct;69(10):613-6. doi: 10.1002/bjs.1800691019.'}, {'pmid': '8019725', 'type': 'BACKGROUND', 'citation': 'Tschmelitsch J, Kronberger P, Glaser K, Klingler A, Bodner E. Survival after surgical treatment of recurrent carcinoma of the rectum. J Am Coll Surg. 1994 Jul;179(1):54-8.'}, {'pmid': '31543678', 'type': 'BACKGROUND', 'citation': 'Feeney G, Sehgal R, Sheehan M, Hogan A, Regan M, Joyce M, Kerin M. Neoadjuvant radiotherapy for rectal cancer management. World J Gastroenterol. 2019 Sep 7;25(33):4850-4869. doi: 10.3748/wjg.v25.i33.4850.'}]}, 'descriptionModule': {'briefSummary': 'Tumor recurrence after curative surgical resection for rectal cancer is a serious complication that greatly affects the overall morbidity and the outcome. This study aims to identify the different prognostic factors affecting recurrence and disease-free survival after surgery.', 'detailedDescription': "A retrospective analysis of patients operated for cancer rectum with curative intent from.\n\nExclusion criteria will include patients with familial adenomatous polyposis, multiple synchronous or metachronous rectal cancers, and death within 3 months. Incomplete patients' files and patients that lost follow-up will be excluded.\n\nDemographic, histopathological, follow up and outcome data will be collected from completed patients' files. Demographics include age, gender, family history, and chief complaint at the presentation. Histopathological data include tumor grade, vascular-perineural invasion, the total number of lymph nodes removed, and positive lymph nodes.\n\nLymph node ratio will be defined as the ratio of positive lymph nodes to the total number of retrieved lymph nodes in a histopathology specimen. Disease-free survival will be calculated for each patient based on the time of surgery to the time of recurrence detection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- Patients who had curative surgery for cancer rectum.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had curative surgery for cancer rectum.\n\nExclusion Criteria:\n\n* Patients with familial adenomatous polyposis (FAP), multiple synchronous or metachronous rectal cancers, and death within 3 months\n* Patients that lost follow-up will be excluded.'}, 'identificationModule': {'nctId': 'NCT06096493', 'briefTitle': 'Prognostic Factors Affecting Recurrence and Disease-Free Survival After Surgical Resection for Cancer Rectum', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Predictors of Disease Free Survival After Curative Cancer Rectum Surgery', 'orgStudyIdInfo': {'id': 'SVU-MED-SUR011-4-23-4-621'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with cancer rectum underwent curative surgery', 'description': 'Patients with cancer rectum underwent curative surgery', 'interventionNames': ['Procedure: curative surgery for cancer rectum']}], 'interventions': [{'name': 'curative surgery for cancer rectum', 'type': 'PROCEDURE', 'description': 'Curative surgery for cancer rectum.', 'armGroupLabels': ['Patients with cancer rectum underwent curative surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qina', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Abdallah M Taha, MD', 'role': 'CONTACT', 'email': 'abdallahsurgery@med.svu.edu.eg', 'phone': '+201011617497'}, {'name': 'Abdallah M Taha, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Qena Faculty of Medicine, South Valley University Hospitals', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}], 'centralContacts': [{'name': 'Abdallah M Taha, MD', 'role': 'CONTACT', 'email': 'abdallahsurgery@med.svu.edu.eg', 'phone': '+201011716497'}], 'overallOfficials': [{'name': 'Abdallah M Taha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Valley University, Egypt.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of general Surgery', 'investigatorFullName': 'Abdallah Mohamed Taha Aly', 'investigatorAffiliation': 'South Valley University'}}}}