Exploring the Application of 3D Bioprinting for Personalized Treatment in Pancreatic Ductal Adenocarcinoma

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Exploring the Application of 3D Bioprinting Technology in Constructing Preclinical Models of Pancreatic Cancer for Drug Sensitivity Testing and Its Significance in Personalized Treatment

ClinicalTrials.gov ID

NCT05955092

Acronym / sponsor ID

PDAC3DP001

Conditions

Pancreatic Ductal Adenocarcinoma

Study type

Observational

Recruitment status

Unknown status

Enrolment

30 participants (estimated)

Lead sponsor

Peking Union Medical College HospitalUniversity, hospital or other

Study start

1 Dec 2022 (actual)

Primary completion

30 Jun 2024 (estimated)

Study completion

30 Sep 2024 (estimated)

First posted

21 Jul 2023 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Case only

Time perspective

Cross-sectional

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients

   Time frame: From enrollment to end within 2 weeks

   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). 2. 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.

Results and safety

Results are not available in the source record.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
• Background: PubMed 25557080Boj 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.
• Background: PubMed 34789479Grossman 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.
• Background: PubMed 29853643Tiriac 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.
• Results publication: PubMed 33007612Xie 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.
• Results publication: PubMed 32582546Sun 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.
• Individual participant dataSharing planned: Yes. Individual participant data (IPD) can be accessed with reasonable requests via e-mail. IPD will be shared after the study is completed.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

2 sites in 1 country: see every site and its status.