Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2026-03-29 @ 10:48 AM
Study NCT ID:
NCT04049461
Status:
NOT_YET_RECRUITING
Last Update Posted:
2019-08-08
First Post:
2019-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heterotopic Ossification in Abdominal Incision and Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D009999', 'term': 'Ossification, Heterotopic'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The ossification patients were sequenced with informed consent . Promise to keep their personal information confidential.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-06', 'studyFirstSubmitDate': '2019-08-06', 'studyFirstSubmitQcDate': '2019-08-06', 'lastUpdatePostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'Patients with pancreatic cancer were divided into HOAI and non-HOAI groups to determine whether there were differences between the OS of two groups.'}], 'primaryOutcomes': [{'measure': 'Incidence of HOAI', 'timeFrame': '12 months', 'description': 'HOAI is determined by CT, whose CT number is similar to that of the same spine.'}, {'measure': 'Bone alkaline phosphatase', 'timeFrame': '12 months', 'description': 'Preoperative tests were performed and every three months postoperatively'}], 'secondaryOutcomes': [{'measure': 'Incidence of distant metastasis and local recurrence', 'timeFrame': '12 months', 'description': 'Patients with pancreatic cancer were divided into HOAI and non-HOAI groups to determine whether there were differences in the incidence of distant metastasis and local recurrence between the two groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer of Pancreas', 'Ossification, Heterotopic', 'Abdominal incision'], 'conditions': ['Cancer of Pancreas', 'Ossification, Heterotopic']}, 'referencesModule': {'references': [{'pmid': '25075838', 'type': 'BACKGROUND', 'citation': 'Ghuman MS, Saggar K. Images in clinical medicine. Heterotopic ossification of a midline abdominal incision. N Engl J Med. 2014 Jul 31;371(5):464. doi: 10.1056/NEJMicm1312006. No abstract available.'}, {'pmid': '19204446', 'type': 'BACKGROUND', 'citation': 'Kim J, Kim Y, Jeong WK, Song SY, Cho OK. Heterotopic ossification developing in surgical incisions of the abdomen: analysis of its incidence and possible factors associated with its development. J Comput Assist Tomogr. 2008 Nov-Dec;32(6):872-6. doi: 10.1097/RCT.0b013e318159c617.'}, {'pmid': '20400341', 'type': 'BACKGROUND', 'citation': 'Koolen PG, Schreinemacher MH, Peppelenbosch AG. Heterotopic ossifications in midline abdominal scars: a critical review of the literature. Eur J Vasc Endovasc Surg. 2010 Aug;40(2):155-9. doi: 10.1016/j.ejvs.2010.03.010. Epub 2010 Apr 18.'}, {'pmid': '27098323', 'type': 'BACKGROUND', 'citation': 'Isaacson BM, Potter BK, Bloebaum RD, Epperson RT, Kawaguchi BS, Swanson TM, Pasquina PF. Link Between Clinical Predictors of Heterotopic Ossification and Histological Analysis in Combat-Injured Service Members. J Bone Joint Surg Am. 2016 Apr 20;98(8):647-57. doi: 10.2106/JBJS.15.00895.'}, {'pmid': '26643987', 'type': 'BACKGROUND', 'citation': 'Citak M, Grasmucke D, Suero EM, Cruciger O, Meindl R, Schildhauer TA, Aach M. The roles of serum alkaline and bone alkaline phosphatase levels in predicting heterotopic ossification following spinal cord injury. Spinal Cord. 2016 May;54(5):368-70. doi: 10.1038/sc.2015.211. Epub 2015 Dec 8.'}]}, 'descriptionModule': {'briefSummary': 'To investigate whether pancreatic cancer is the cause of heterotopic ossification of abdominal incision.', 'detailedDescription': 'Heterotopic ossification of abdominal incision (HOAI) has long been regarded as a rare complication after general surgery. However,according to our retrospective analysis. HOAI was more frequently observed in the malignancy group (33/121 cases, 27.3%) than in the non- malignancy group. Because of the many biases in the retrospective analysis, the result was not widely shared.\n\nThe purpose of this prospective study is to confirm that pancreatic cancer is the cause of heterotopic ossification of abdominal incisions. According to postoperative pathology, the patients were divided into two groups: pancreatic cancer group and benign diseases group.The researchers will observe whether patients develop heterotopic ossification of the abdominal incision one year after surgery to conclude.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese Han population', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Obtain informed consent from the patients.\n* The patient's abdominal incision was double-closed with continuous suture of linea alba and fascia with absorbable suture, and skin was sutured with skin staples.\n\nExclusion Criteria:\n\n* Refusing to join the study\n* Previous history of malignant tumor\n* Previous history of midabdominal incision\n* Abnormal calcium and phosphorus metabolism\n* Distant metastasis\n* Palliative operation\n* performing neoadjuvant chemotherapy"}, 'identificationModule': {'nctId': 'NCT04049461', 'briefTitle': 'Heterotopic Ossification in Abdominal Incision and Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'The Causes of Heterotopic Ossification in Abdominal Incision After Pancreatic Surgery：A Single-center Prospective Study', 'orgStudyIdInfo': {'id': 'NMU-JSPH-PC-Ossification'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PDAC Group', 'description': 'Radical operations were performed through central abdominal incisions. The postoperative pathology was pancreatic ductal adenocarcinoma.', 'interventionNames': ['Diagnostic Test: Bone alkaline phosphatase', 'Radiation: Abdominal CT scan']}, {'label': 'Benign Group', 'description': 'The abdominal midline incision was performed and the postoperative pathology was benign.', 'interventionNames': ['Diagnostic Test: Bone alkaline phosphatase', 'Radiation: Abdominal CT scan']}], 'interventions': [{'name': 'Bone alkaline phosphatase', 'type': 'DIAGNOSTIC_TEST', 'description': 'Hematologic indicators reflecting ossification.', 'armGroupLabels': ['Benign Group', 'PDAC Group']}, {'name': 'Abdominal CT scan', 'type': 'RADIATION', 'description': 'Observe whether HOAI occurs.', 'armGroupLabels': ['Benign Group', 'PDAC Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The first affiliated hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Jishu Wei, MD,PhD', 'role': 'CONTACT', 'email': 'weijishu@njmu.edu.cn', 'phone': '086-025-68136891'}], 'overallOfficials': [{'name': 'Yi Miao, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pancreas Center, The First Affiliated Hospital of Nanjing Medical University'}, {'name': 'Junli Wu, MD,PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pancreas Center, The First Affiliated Hospital of Nanjing Medical University'}, {'name': 'Jishu Wei, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pancreas Center, The First Affiliated Hospital of Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Pancreas Center', 'investigatorFullName': 'Yi Miao, Prof.', 'investigatorAffiliation': 'Nanjing Medical University'}}}}