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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Sheng Tai, M.D.
- 전화번호: 0551-62922234 86-18355159268
- 이메일: Taishengwk@163.com
연구 연락처 백업
- 이름: Bowen Li, M.D.
- 전화번호: 0551-62922234 86-18356721482
- 이메일: 2534582952@qq.com
연구 장소
-
-
Anhui
-
Hefei, Anhui, 중국, 230022
- Universitythe First Affiliatedhospital of Anhuimedical
-
연락하다:
- Sheng Tai, M.D.
- 전화번호: 0551-62922234 86-18355159268
- 이메일: Taishengwk@163.com
-
연락하다:
- Bowen Li, M.D.
- 전화번호: 0551-62922234 86-18356721482
- 이메일: 2534582952@qq.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Persistent PSA elevation
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Biochemical Progression-Free Survival (bPFS)
기간: 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.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Sheng Tai, M.D., THE FIRST AFFILIATED HOSPITAL OF ANHUI MEDICALUNIVERSITY
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- KY2026-09-80
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .