Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-29 @ 9:45 PM
Study NCT ID:
NCT05955092
Status:
UNKNOWN
Last Update Posted:
2023-07-21
First Post:
2023-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Application of 3D Bioprinting for Personalized Treatment in Pancreatic Ductal Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2023-07-04', 'studyFirstSubmitQcDate': '2023-07-12', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients', 'timeFrame': 'From enrollment to end within 2 weeks', 'description': "1. Evaluation of the efficacy of neoadjuvant therapy in clinical response using the internationally recognized Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Stable Disease (SD) and Partial Response (PR) are considered indicators of chemotherapy sensitivity (good response), while Progressive Disease (PD) is considered indicative of chemotherapy resistance (poor response).\n2. Drug sensitivity testing results were assessed using standardized IC50 values. The standardized IC50 values were treated as the testing variables, while the clinical response to chemotherapy was designated as the state variable. The ROC curves for both variables were analyzed, and the area under the curve (AUC) was calculated to assess their correlation. To analyze the correlation between the drug testing results and clinical prognosis, linear regression analysis was performed to evaluate the correlation between standardized IC50 values and patients' progression-free survival (PFS) values."}], 'secondaryOutcomes': [{'measure': 'Progression-free survival time (PFS)', 'timeFrame': 'Up to 2 years.', 'description': 'The time from the start of postoperative adjuvant therapy to recurrence or death.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Ductal Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '25557080', 'type': 'BACKGROUND', 'citation': 'Boj SF, Hwang CI, Baker LA, Chio II, Engle DD, Corbo V, Jager M, Ponz-Sarvise M, Tiriac H, Spector MS, Gracanin A, Oni T, Yu KH, van Boxtel R, Huch M, Rivera KD, Wilson JP, Feigin ME, Ohlund D, Handly-Santana A, Ardito-Abraham CM, Ludwig M, Elyada E, Alagesan B, Biffi G, Yordanov GN, Delcuze B, Creighton B, Wright K, Park Y, Morsink FH, Molenaar IQ, Borel Rinkes IH, Cuppen E, Hao Y, Jin Y, Nijman IJ, Iacobuzio-Donahue C, Leach SD, Pappin DJ, Hammell M, Klimstra DS, Basturk O, Hruban RH, Offerhaus GJ, Vries RG, Clevers H, Tuveson DA. Organoid models of human and mouse ductal pancreatic cancer. Cell. 2015 Jan 15;160(1-2):324-38. doi: 10.1016/j.cell.2014.12.021. Epub 2014 Dec 31.'}, {'pmid': '34789479', 'type': 'BACKGROUND', 'citation': 'Grossman JE, Muthuswamy L, Huang L, Akshinthala D, Perea S, Gonzalez RS, Tsai LL, Cohen J, Bockorny B, Bullock AJ, Schlechter B, Peters MLB, Conahan C, Narasimhan S, Lim C, Davis RB, Besaw R, Sawhney MS, Pleskow D, Berzin TM, Smith M, Kent TS, Callery M, Muthuswamy SK, Hidalgo M. Organoid Sensitivity Correlates with Therapeutic Response in Patients with Pancreatic Cancer. Clin Cancer Res. 2022 Feb 15;28(4):708-718. doi: 10.1158/1078-0432.CCR-20-4116.'}, {'pmid': '29853643', 'type': 'BACKGROUND', 'citation': "Tiriac H, Belleau P, Engle DD, Plenker D, Deschenes A, Somerville TDD, Froeling FEM, Burkhart RA, Denroche RE, Jang GH, Miyabayashi K, Young CM, Patel H, Ma M, LaComb JF, Palmaira RLD, Javed AA, Huynh JC, Johnson M, Arora K, Robine N, Shah M, Sanghvi R, Goetz AB, Lowder CY, Martello L, Driehuis E, LeComte N, Askan G, Iacobuzio-Donahue CA, Clevers H, Wood LD, Hruban RH, Thompson E, Aguirre AJ, Wolpin BM, Sasson A, Kim J, Wu M, Bucobo JC, Allen P, Sejpal DV, Nealon W, Sullivan JD, Winter JM, Gimotty PA, Grem JL, DiMaio DJ, Buscaglia JM, Grandgenett PM, Brody JR, Hollingsworth MA, O'Kane GM, Notta F, Kim E, Crawford JM, Devoe C, Ocean A, Wolfgang CL, Yu KH, Li E, Vakoc CR, Hubert B, Fischer SE, Wilson JM, Moffitt R, Knox J, Krasnitz A, Gallinger S, Tuveson DA. Organoid Profiling Identifies Common Responders to Chemotherapy in Pancreatic Cancer. Cancer Discov. 2018 Sep;8(9):1112-1129. doi: 10.1158/2159-8290.CD-18-0349. Epub 2018 May 31."}, {'pmid': '33007612', 'type': 'RESULT', 'citation': 'Xie F, Sun L, Pang Y, Xu G, Jin B, Xu H, Lu X, Xu Y, Du S, Wang Y, Feng S, Sang X, Zhong S, Wang X, Sun W, Zhao H, Zhang H, Yang H, Huang P, Mao Y. Three-dimensional bio-printing of primary human hepatocellular carcinoma for personalized medicine. Biomaterials. 2021 Jan;265:120416. doi: 10.1016/j.biomaterials.2020.120416. Epub 2020 Sep 22.'}, {'pmid': '32582546', 'type': 'RESULT', 'citation': 'Sun L, Yang H, Wang Y, Zhang X, Jin B, Xie F, Jin Y, Pang Y, Zhao H, Lu X, Sang X, Zhang H, Lin F, Sun W, Huang P, Mao Y. Application of a 3D Bioprinted Hepatocellular Carcinoma Cell Model in Antitumor Drug Research. Front Oncol. 2020 Jun 3;10:878. doi: 10.3389/fonc.2020.00878. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to test the application value of 3D bioprinting technology in personalized treatment of pancreatic cancer.\n\nThe main questions it aims to answer are:\n\n* Can 3D bioprinting technology be successfully applied to establish preclinical models of pancreatic cancer?\n* Can 3D bioprinted preclinical models of pancreatic cancer be applied to personalized treatment of pancreatic cancer?\n\nParticipants will have tumor tissue collected to extract primary tumor cells for the establishment of in vitro preclinical models, which will be used for drug sensitivity testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients with clinically and pathologically confirmed pancreatic ductal adenocarcinoma are considered potential candidates for this study. Clinical physicians will comprehensively document the medical history, including only patients above 18 years of age. Individuals with other malignant tumors or severe diseases will be excluded. Patients who are unable to provide independent informed consent will not be included in this study. All patients in this study will undergo adjuvant/neoadjuvant chemotherapy and surgical resection for the treatment of localized pancreatic ductal adenocarcinoma.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 18 years old\n* Diagnosed as colorectal cancer with or without liver metastases before\n* Pathologically proven colorectal cancer after surgery\n\nExclusion Criteria:\n\n* History of other malignancies or serious medical conditions\n* Inability to provide independent informed consent'}, 'identificationModule': {'nctId': 'NCT05955092', 'briefTitle': 'Exploring the Application of 3D Bioprinting for Personalized Treatment in Pancreatic Ductal Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Exploring the Application of 3D Bioprinting Technology in Constructing Preclinical Models of Pancreatic Cancer for Drug Sensitivity Testing and Its Significance in Personalized Treatment', 'orgStudyIdInfo': {'id': 'PDAC3DP001'}}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongliang Sun, MD', 'role': 'CONTACT', 'email': 'sunyongliang1982@hotmail.com'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yilei Mao, MD PhD', 'role': 'CONTACT', 'email': 'pumch-liver@hotmail.com', 'phone': '8600-010-69156042'}, {'name': 'Hang Sun, MD', 'role': 'CONTACT', 'email': 'hangsunkcs@163.com', 'phone': '8600-15626041366'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yilei Mao', 'role': 'CONTACT', 'email': 'pumch-liver@hotmail.com', 'phone': '8600-010-69156042'}, {'name': 'Hang Sun', 'role': 'CONTACT', 'email': 'hangsunkcs@163.com', 'phone': '8600-15626041366'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The IPD data will available after the study is completed.', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) can be accessed with reasonable requests via e-mail. IPD will be shared after the study is completed.', 'accessCriteria': 'Data can be accessed via e-mail with reasonable requests.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}