Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 1:03 AM
Study NCT ID:
NCT06242457
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2024-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Poorly Differentiated Adenocarcinoma of the Jejunum in a Patient With Peutz-Jeghers Syndrome: A Case Report
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010580', 'term': 'Peutz-Jeghers Syndrome'}], 'ancestors': [{'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D044483', 'term': 'Intestinal Polyposis'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007911', 'term': 'Lentigo'}, {'id': 'D008548', 'term': 'Melanosis'}, {'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-02', 'studyFirstSubmitDate': '2024-01-29', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete resection of adenocarcinomas located in the jejunum or ileum is associated with 5-year survival rates of 20% to 30%.', 'timeFrame': '5months', 'description': 'Even though small bowel malignancy is a rare entity, early detection is a challenging issue, especially when it happens below the ligaments of the trietz. Peutz-Jeghers syndrome was a potential risk factor in our case.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peutz-Jeghers Syndrome']}, 'descriptionModule': {'briefSummary': 'Our study is a case report of one of the rarest risk factor, Peutz-Jeghers syndrome, of small bowel malignancy detected in a patient with poorly differentiated adenocarcinoma of small bowel(jejunum)', 'detailedDescription': 'Case presentation: A 25-year-old male patient presented to the emergency department with generalized peritonitis caused by a perforated jejunal mass. The patient underwent an emergency exploratory laparotomy. There was 800 ml of thin pus in the peritoneal cavity and 5 cm by 6 cm perforated mass over the jejunum, 30cm from the ligament of the treitz, which extends to the mesentery. Palpable jejunal mesenteric lymphadenopathies were found. There were palpable intraluminal polyps with an inverted serosal surface for some of them, which were identified as 10cm proximal and 20cm distal to the mass. The pus was sucked out, and the mass was resected with its mesenteric lymph nodes and segments containing polyps, a total of 40cm of jejunum. Subsequently, end-to-end hand-sewn anastomosis was performed, and the abdomen was closed. The histopathology report showed poorly differentiated adenocarcinoma, stage IIIC (PT3, PN2), and Peutz-Jeghers polyps, suggesting Peutz-Jeghers syndrome. Lympho-vascular invasion was also noted. The tumor has affected seven of the 12 lymph nodes that have been identified. After 6weeks of uneventful follow-up at the surgical referral clinic, the patient was referred to the oncology department for adjuvant chemotherapy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'New patient came to emergency department as routine activity.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* not necessary\n\nExclusion Criteria:\n\n* not necessary'}, 'identificationModule': {'nctId': 'NCT06242457', 'briefTitle': 'Poorly Differentiated Adenocarcinoma of the Jejunum in a Patient With Peutz-Jeghers Syndrome: A Case Report', 'organization': {'class': 'OTHER', 'fullName': 'Haramaya Unversity'}, 'officialTitle': 'Poorly Differentiated Adenocarcinoma of the Jejunum in a Patient With Peutz-Jeghers Syndrome: A Case Report', 'orgStudyIdInfo': {'id': 'HU'}}, 'contactsLocationsModule': {'locations': [{'city': 'Harar', 'country': 'Ethiopia', 'facility': 'Haramaya University', 'geoPoint': {'lat': 9.31387, 'lon': 42.11815}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'after publication', 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haramaya Unversity', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Assistant professor of general surgery', 'investigatorFullName': 'Fufa Miresa', 'investigatorAffiliation': 'Haramaya Unversity'}}}}