- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07818395
Spatial Multi-Omics of Perineural Invasion Microenvironment and Prognosis in Prostate Cancer
Study on Spatial Multi-Omics Deciphering of the Perineural Invasion Microenvironment and Its Prognostic Value in Prostate Cancer
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This study will utilize tissue specimens and clinical follow-up data from prostate cancer patients, integrating HE/WSI pathological images, spatial transcriptomics, spatial proteomics, whole-exome sequencing (WES), and single-cell transcriptomics to systematically characterize the cellular composition, spatial proximity relationships, molecular expression profiles, and genomic alterations within the perineural invasion (PNI) microenvironment of prostate cancer.
Specifically, this study aims to delineate the spatial multi-omics differences among PNI-positive regions, PNI-negative tumor regions, and adjacent-normal regions; to screen for candidate molecular markers associated with PNI burden, local tumor aggressiveness, and poor postoperative outcomes; and to explore the establishment of a PNI classification and prognostic risk assessment model based on spatial multi-omics features, thereby providing a foundation for individualized risk stratification and future mechanistic investigations in prostate cancer.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Sheng Tai, M.D.
- Telefoonnummer: 0551-62922234 86-18355159268
- E-mail: Taishengwk@163.com
Studie Contact Back-up
- Naam: Bowen Li, M.D.
- Telefoonnummer: 0551-62922234 86-18356721482
- E-mail: 2534582952@qq.com
Studie Locaties
-
-
Anhui
-
Hefei, Anhui, China, 230022
- Universitythe First Affiliatedhospital of Anhuimedical
-
Contact:
- Sheng Tai, M.D.
- Telefoonnummer: 0551-62922234 86-18355159268
- E-mail: Taishengwk@163.com
-
Contact:
- Bowen Li, M.D.
- Telefoonnummer: 0551-62922234 86-18356721482
- E-mail: 2534582952@qq.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
(1)Age >18 years and <85 years. (2)Histopathologically confirmed prostate cancer, including prostatic acinar adenocarcinoma, ductal adenocarcinoma, intraductal carcinoma, or other pathological types deemed suitable for inclusion by the investigator.
(3)Have undergone radical prostatectomy, prostate biopsy, or other clinical diagnostic or therapeutic procedures, and have prostate tissue specimens obtained and available for research purposes.
(4)Tissue specimens meet the basic quality requirements for HE pathological assessment, spatial transcriptomics, spatial proteomics, whole-exome sequencing (WES), or single-cell transcriptome sequencing.
(5)Have available basic clinical data, pathological data, treatment information, and follow-up data, including PSA levels, pathological grade, pathological stage, margin status, perineural invasion (PNI) status, and postoperative re-examination information.
(6)For prospectively enrolled new patients, written informed consent must be voluntarily signed. For archived leftover specimens and medical records obtained during prior clinical care, a waiver of informed consent or waiver of documentation of informed consent may be applied for, provided that ethical requirements are satisfied.
Exclusion Criteria:
(1)Insufficient tissue sample quantity, severe disruption of tissue architecture, excessively low tumor cellularity, or nucleic acid/protein quality that fails to meet the requirements for the intended assays.
(2)Severe deficiency in clinicopathological data, precluding the determination of perineural invasion (PNI) status, major pathological parameters, or key follow-up outcomes.
(3)Concurrent other malignancies that, in the investigator's judgment, may significantly affect the prognostic assessment of prostate cancer.
(4)The patient explicitly refuses to allow their samples or clinical information to be used for scientific research.
(5)Other conditions deemed unsuitable for inclusion in this study by the investigator.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Patients who have prostate cancer tissue specimens collected during urological care at the First Aff
|
HE/WSI pathological image analysis Xenium spatial transcriptomics PhenoCycler-Fusion spatial proteomics Whole-exome sequencing (WES) Single-cell transcriptome sequencing
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Persistent PSA elevation
Tijdsspanne: post-operative PSA levels at 6-8 weeks and 3 months
|
Record PSA levels at 6-8 weeks and 3 months post-surgery; predefined thresholds in the study protocol may be used for exploratory analyses.
|
post-operative PSA levels at 6-8 weeks and 3 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Biochemical Progression-Free Survival (bPFS)
Tijdsspanne: From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (+1 month) for up to 24 months.
|
Time from initiation of ADT plus ARPl therapy to biochemical progression or deathfrom any cause, whichever occurs first.
Biochemical progression is defined as a PSA rise to a0.2ng/mL after having reached an undetectable level, confirmed by a second measurement at least 2weeks apart.
Participants without an event will be censored at the date of last follow-up.
|
From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (+1 month) for up to 24 months.
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Sheng Tai, M.D., THE FIRST AFFILIATED HOSPITAL OF ANHUI MEDICALUNIVERSITY
Publicaties en nuttige links
Algemene publicaties
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Stahl PL, Salmen F, Vickovic S, Lundmark A, Navarro JF, Magnusson J, Giacomello S, Asp M, Westholm JO, Huss M, Mollbrink A, Linnarsson S, Codeluppi S, Borg A, Ponten F, Costea PI, Sahlen P, Mulder J, Bergmann O, Lundeberg J, Frisen J. Visualization and analysis of gene expression in tissue sections by spatial transcriptomics. Science. 2016 Jul 1;353(6294):78-82. doi: 10.1126/science.aaf2403.
- Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006. eCollection 2024 Mar.
- Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322/caac.21820. Epub 2024 Jan 17.
- Akhoundova D, Rubin MA. Clinical application of advanced multi-omics tumor profiling: Shaping precision oncology of the future. Cancer Cell. 2022 Sep 12;40(9):920-938. doi: 10.1016/j.ccell.2022.08.011. Epub 2022 Sep 1.
- Punnen S, Cooperberg MR, D'Amico AV, Karakiewicz PI, Moul JW, Scher HI, Schlomm T, Freedland SJ. Management of biochemical recurrence after primary treatment of prostate cancer: a systematic review of the literature. Eur Urol. 2013 Dec;64(6):905-15. doi: 10.1016/j.eururo.2013.05.025. Epub 2013 May 16.
- Chen S, Lake BB, Zhang K. High-throughput sequencing of the transcriptome and chromatin accessibility in the same cell. Nat Biotechnol. 2019 Dec;37(12):1452-1457. doi: 10.1038/s41587-019-0290-0. Epub 2019 Oct 14.
- Marx V. Publisher Correction: Method of the Year: spatially resolved transcriptomics. Nat Methods. 2021 Feb;18(2):219. doi: 10.1038/s41592-021-01065-y. No abstract available.
- Rodriques SG, Stickels RR, Goeva A, Martin CA, Murray E, Vanderburg CR, Welch J, Chen LM, Chen F, Macosko EZ. Slide-seq: A scalable technology for measuring genome-wide expression at high spatial resolution. Science. 2019 Mar 29;363(6434):1463-1467. doi: 10.1126/science.aaw1219. Epub 2019 Mar 28.
- Berglund E, Maaskola J, Schultz N, Friedrich S, Marklund M, Bergenstrahle J, Tarish F, Tanoglidi A, Vickovic S, Larsson L, Salmen F, Ogris C, Wallenborg K, Lagergren J, Stahl P, Sonnhammer E, Helleday T, Lundeberg J. Spatial maps of prostate cancer transcriptomes reveal an unexplored landscape of heterogeneity. Nat Commun. 2018 Jun 20;9(1):2419. doi: 10.1038/s41467-018-04724-5.
- Zhang LJ, Wu B, Zha ZL, Qu W, Zhao H, Yuan J, Feng YJ. Perineural invasion as an independent predictor of biochemical recurrence in prostate cancer following radical prostatectomy or radiotherapy: a systematic review and meta-analysis. BMC Urol. 2018 Feb 1;18(1):5. doi: 10.1186/s12894-018-0319-6.
- Magnon C, Hall SJ, Lin J, Xue X, Gerber L, Freedland SJ, Frenette PS. Autonomic nerve development contributes to prostate cancer progression. Science. 2013 Jul 12;341(6142):1236361. doi: 10.1126/science.1236361.
- Liebig C, Ayala G, Wilks JA, Berger DH, Albo D. Perineural invasion in cancer: a review of the literature. Cancer. 2009 Aug 1;115(15):3379-91. doi: 10.1002/cncr.24396.
- Harnden P, Shelley MD, Clements H, Coles B, Tyndale-Biscoe RS, Naylor B, Mason MD. The prognostic significance of perineural invasion in prostatic cancer biopsies: a systematic review. Cancer. 2007 Jan 1;109(1):13-24. doi: 10.1002/cncr.22388.
- Bismar TA, Lewis JS Jr, Vollmer RT, Humphrey PA. Multiple measures of carcinoma extent versus perineural invasion in prostate needle biopsy tissue in prediction of pathologic stage in a screening population. Am J Surg Pathol. 2003 Apr;27(4):432-40. doi: 10.1097/00000478-200304000-00002.
- Hamdy FC, Donovan JL, Lane JA, Metcalfe C, Davis M, Turner EL, Martin RM, Young GJ, Walsh EI, Bryant RJ, Bollina P, Doble A, Doherty A, Gillatt D, Gnanapragasam V, Hughes O, Kockelbergh R, Kynaston H, Paul A, Paez E, Powell P, Rosario DJ, Rowe E, Mason M, Catto JWF, Peters TJ, Oxley J, Williams NJ, Staffurth J, Neal DE; ProtecT Study Group. Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2023 Apr 27;388(17):1547-1558. doi: 10.1056/NEJMoa2214122. Epub 2023 Mar 11.
- Chen R, Ren S; Chinese Prostate Cancer Consortium; Yiu MK, Fai NC, Cheng WS, Ian LH, Naito S, Matsuda T, Kehinde E, Kural A, Chiu JY, Umbas R, Wei Q, Shi X, Zhou L, Huang J, Huang Y, Xie L, Ma L, Yin C, Xu D, Xu K, Ye Z, Liu C, Ye D, Gao X, Fu Q, Hou J, Yuan J, He D, Pan T, Ding Q, Jin F, Shi B, Wang G, Liu X, Wang D, Shen Z, Kong X, Xu W, Deng Y, Xia H, Cohen AN, Gao X, Xu C, Sun Y. Prostate cancer in Asia: A collaborative report. Asian J Urol. 2014 Oct;1(1):15-29. doi: 10.1016/j.ajur.2014.08.007. Epub 2015 Apr 16.
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- KY2026-09-80
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .