Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-26 @ 11:59 AM
Study NCT ID:
NCT06978595
Status:
COMPLETED
Last Update Posted:
2025-05-18
First Post:
2025-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Colorectal Signet Ring Cell Carcinoma and the Risk of Multiple Primary Gastrointestinal Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018279', 'term': 'Carcinoma, Signet Ring Cell'}], '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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018297', 'term': 'Neoplasms, Cystic, Mucinous, and Serous'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8171}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2025-05-16', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The standardized incidence ratio of developing gastrointestinal second primary malignancies following primary colorectal signet ring cell carcinoma', 'timeFrame': 'from Jan, 2000 till Dec, 2021', 'description': 'The surveillance, epidemiology and End Results (SEER) database was used to calculate the standardized incidence ratio (SIR) as Observed/Expected (O/E) for second primary gastrointestinal malignancies. Patients diagnosed with primary colorectal SRCC between 2000 and 2021 were included. The event was defined as the appearance of an SPM in a different site from the original cancer at a new GI organ (esophagus, stomach, small intestine, cecum, appendix, rectum, anus and anal canal, liver, gallbladder, intrahepatic bile duct, pancreas, retro-peritoneum, and colon).'}], 'secondaryOutcomes': [{'measure': 'The excess risk of developing gastrointestinal second primary malignancies following primary colorectal signet ring cell carcinoma', 'timeFrame': 'from Jan, 2000 till Dec, 2021', 'description': 'The excess risk per 10,000 was calculated using SEER\\*stat software.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['signet ring carcinoma', 'SEER', 'Cancer'], 'conditions': ['Colorectal Carcinoma', 'Cancer', 'Signet Ring Adenocarcinoma of the Colon']}, 'descriptionModule': {'briefSummary': 'This original research investigates the critical issue of gastrointestinal (GI) second primary malignancies (SPMs) in patients with signet ring cell carcinoma (SRCC), a rare and aggressive subtype of colorectal cancer. Utilizing the Surveillance, Epidemiology, and End Results (SEER) database, the investigators assessed the risk of GI SPMs, particularly within 2-11 months post-SRCC diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with primary colorectal SRCC between 2000 and 2021 were included. Demographic characteristics extracted included race (White, Black, and other races: American Indian/Alaska Native and Asian/Pacific Islander), age (pediatrics: \\<18 years, young adults: 18-39 years, middle-aged: 40-64 years, elderly: ≥65 years, according to the WHO classification), marital status (married, unmarried, or unknown), and year of diagnosis. Tumor-related variables included stage (in situ, localized, regional, distant, per SEER staging definitions \\[19\\]), tumor grade (well-differentiated/grade I, moderately differentiated/grade II, poorly differentiated/grade III, undifferentiated anaplastic/grade IV, and unknown grade), and treatment-related variables (chemotherapy, radiation, and surgery).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with primary colorectal SRCC between 2000 and 2021\n* Latency exclusion period of two months\n\nExclusion Criteria:\n\n* patients with unknown age data'}, 'identificationModule': {'nctId': 'NCT06978595', 'briefTitle': 'Primary Colorectal Signet Ring Cell Carcinoma and the Risk of Multiple Primary Gastrointestinal Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Suez Canal University'}, 'officialTitle': 'Primary Colorectal Signet Ring Cell Carcinoma and the Risk of Multiple Primary Gastrointestinal Malignancies: a Retrospective Cohort Based on SEER Database From 2000-2021', 'orgStudyIdInfo': {'id': 'Z2730'}}, 'contactsLocationsModule': {'locations': [{'zip': '41512', 'city': 'Ismailia', 'country': 'Egypt', 'facility': 'Suez Canal University', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'asmaa salama ibrahim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident physician of gastroenterology', 'investigatorFullName': 'asmaa salama ibrahim', 'investigatorAffiliation': 'Suez Canal University'}}}}