- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07818421
Intratumoral Microbiota and Immune Microenvironment in Prostate Cancer
Study on the Characteristics of Intratumoral Microbiota in Prostate Cancer and Their Relationship With the Tumor Immune Microenvironment
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Sheng Tai, M.D.
- Numero di telefono: 0551-62922234 86-18355159268
- Email: Taishengwk@163.com
Backup dei contatti dello studio
- Nome: Bowen Li, M.D.
- Numero di telefono: 0551-62922234 86-18356721482
- Email: 2534582952@qq.com
Luoghi di studio
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Anhui
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Hefei, Anhui, Cina, 230022
- Universitythe First Affiliatedhospital of Anhuimedical
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Contatto:
- Sheng S Tai, M.D.
- Numero di telefono: 0551-62922234 86-18355159268
- Email: Taishengwk@163.com
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Contatto:
- Bowen H Li, M.D.
- Numero di telefono: 0551-62922234 86-18356721482
- Email: 2534582952@qq.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
(1)Age ≥18 years, male.(2)Patients with a pathological diagnosis of prostate cancer, or patients with benign prostatic diseases who undergo diagnostic workup or treatment and are eligible to serve as control samples.(3)Patients who undergo prostate biopsy, transurethral prostate surgery, radical prostatectomy, or other relevant diagnostic or therapeutic procedures at the First Affiliated Hospital of Anhui Medical University.(4)Have available residual tissue samples, formalin-fixed paraffin-embedded (FFPE) tissues, frozen tissues, pathological slides, or existing assay data that can be used for research purposes.(5)Have basic clinicopathological data available; postoperative PSA and follow-up information may be obtained when necessary.(6)For subjects from whom additional residual samples are prospectively collected, or for those who need to be actively contacted for supplementary data, the subject or their legal representative must consent to participate in the study and sign the informed consent form.
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Exclusion Criteria:
(1)Insufficient sample quantity or sample quality that fails to meet the requirements for the intended assays.(2)Severe deficiency in clinicopathological data, rendering the primary analyses unfeasible.(3)Definite risk of contamination during sample storage, transportation, sectioning, extraction, or library preparation, which cannot be reliably ruled out or eliminated through quality control procedures.(4)The patient explicitly refuses to allow their samples or clinical data to be used for research.(5)Other conditions deemed unsuitable for inclusion by the investigator or the ethics committee.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Patients with a pathological diagnosis of prostate cancer, or patients with benign prostatic disease
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Compare microbe-high and microbe-cold areas for differences in immune cell infiltration, macrophage phenotype, T-cell exhaustion/suppression markers, inflammatory factors, and tumor-associated pathways.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Biochemical Progression-Free Survival (bPFS)
Lasso di tempo: From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (+1 month) for up to 24 months.
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Time from initiation of ADT plus ARPI therapy to biochemical progression or deathfrom any cause, whichever occurs first.
Biochemical progression is defined as a PSA rise to 0.2ng/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.
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From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (+1 month) for up to 24 months.
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- 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.
- Eisenhofer R, Minich JJ, Marotz C, Cooper A, Knight R, Weyrich LS. Contamination in Low Microbial Biomass Microbiome Studies: Issues and Recommendations. Trends Microbiol. 2019 Feb;27(2):105-117. doi: 10.1016/j.tim.2018.11.003. Epub 2018 Nov 26.
- de Goffau MC, Lager S, Salter SJ, Wagner J, Kronbichler A, Charnock-Jones DS, Peacock SJ, Smith GCS, Parkhill J. Recognizing the reagent microbiome. Nat Microbiol. 2018 Aug;3(8):851-853. doi: 10.1038/s41564-018-0202-y. No abstract available.
- Salter SJ, Cox MJ, Turek EM, Calus ST, Cookson WO, Moffatt MF, Turner P, Parkhill J, Loman NJ, Walker AW. Reagent and laboratory contamination can critically impact sequence-based microbiome analyses. BMC Biol. 2014 Nov 12;12:87. doi: 10.1186/s12915-014-0087-z.
- Hurst R, Meader E, Gihawi A, Rallapalli G, Clark J, Kay GL, Webb M, Manley K, Curley H, Walker H, Kumar R, Schmidt K, Crossman L, Eeles RA, Wedge DC, Lynch AG, Massie CE; CRUK-ICGC Prostate Group; Yazbek-Hanna M, Rochester M, Mills RD, Mithen RF, Traka MH, Ball RY, O'Grady J, Brewer DS, Wain J, Cooper CS. Microbiomes of Urine and the Prostate Are Linked to Human Prostate Cancer Risk Groups. Eur Urol Oncol. 2022 Aug;5(4):412-419. doi: 10.1016/j.euo.2022.03.006. Epub 2022 Apr 18.
- Cavarretta I, Ferrarese R, Cazzaniga W, Saita D, Luciano R, Ceresola ER, Locatelli I, Visconti L, Lavorgna G, Briganti A, Nebuloni M, Doglioni C, Clementi M, Montorsi F, Canducci F, Salonia A. The Microbiome of the Prostate Tumor Microenvironment. Eur Urol. 2017 Oct;72(4):625-631. doi: 10.1016/j.eururo.2017.03.029. Epub 2017 Apr 20.
- Geller LT, Barzily-Rokni M, Danino T, Jonas OH, Shental N, Nejman D, Gavert N, Zwang Y, Cooper ZA, Shee K, Thaiss CA, Reuben A, Livny J, Avraham R, Frederick DT, Ligorio M, Chatman K, Johnston SE, Mosher CM, Brandis A, Fuks G, Gurbatri C, Gopalakrishnan V, Kim M, Hurd MW, Katz M, Fleming J, Maitra A, Smith DA, Skalak M, Bu J, Michaud M, Trauger SA, Barshack I, Golan T, Sandbank J, Flaherty KT, Mandinova A, Garrett WS, Thayer SP, Ferrone CR, Huttenhower C, Bhatia SN, Gevers D, Wargo JA, Golub TR, Straussman R. Potential role of intratumor bacteria in mediating tumor resistance to the chemotherapeutic drug gemcitabine. Science. 2017 Sep 15;357(6356):1156-1160. doi: 10.1126/science.aah5043.
- Pushalkar S, Hundeyin M, Daley D, Zambirinis CP, Kurz E, Mishra A, Mohan N, Aykut B, Usyk M, Torres LE, Werba G, Zhang K, Guo Y, Li Q, Akkad N, Lall S, Wadowski B, Gutierrez J, Kochen Rossi JA, Herzog JW, Diskin B, Torres-Hernandez A, Leinwand J, Wang W, Taunk PS, Savadkar S, Janal M, Saxena A, Li X, Cohen D, Sartor RB, Saxena D, Miller G. The Pancreatic Cancer Microbiome Promotes Oncogenesis by Induction of Innate and Adaptive Immune Suppression. Cancer Discov. 2018 Apr;8(4):403-416. doi: 10.1158/2159-8290.CD-17-1134. Epub 2018 Mar 22.
- Riquelme E, Zhang Y, Zhang L, Montiel M, Zoltan M, Dong W, Quesada P, Sahin I, Chandra V, San Lucas A, Scheet P, Xu H, Hanash SM, Feng L, Burks JK, Do KA, Peterson CB, Nejman D, Tzeng CD, Kim MP, Sears CL, Ajami N, Petrosino J, Wood LD, Maitra A, Straussman R, Katz M, White JR, Jenq R, Wargo J, McAllister F. Tumor Microbiome Diversity and Composition Influence Pancreatic Cancer Outcomes. Cell. 2019 Aug 8;178(4):795-806.e12. doi: 10.1016/j.cell.2019.07.008.
- Sepich-Poore GD, Zitvogel L, Straussman R, Hasty J, Wargo JA, Knight R. The microbiome and human cancer. Science. 2021 Mar 26;371(6536):eabc4552. doi: 10.1126/science.abc4552.
- Nejman D, Livyatan I, Fuks G, Gavert N, Zwang Y, Geller LT, Rotter-Maskowitz A, Weiser R, Mallel G, Gigi E, Meltser A, Douglas GM, Kamer I, Gopalakrishnan V, Dadosh T, Levin-Zaidman S, Avnet S, Atlan T, Cooper ZA, Arora R, Cogdill AP, Khan MAW, Ologun G, Bussi Y, Weinberger A, Lotan-Pompan M, Golani O, Perry G, Rokah M, Bahar-Shany K, Rozeman EA, Blank CU, Ronai A, Shaoul R, Amit A, Dorfman T, Kremer R, Cohen ZR, Harnof S, Siegal T, Yehuda-Shnaidman E, Gal-Yam EN, Shapira H, Baldini N, Langille MGI, Ben-Nun A, Kaufman B, Nissan A, Golan T, Dadiani M, Levanon K, Bar J, Yust-Katz S, Barshack I, Peeper DS, Raz DJ, Segal E, Wargo JA, Sandbank J, Shental N, Straussman R. The human tumor microbiome is composed of tumor type-specific intracellular bacteria. Science. 2020 May 29;368(6494):973-980. doi: 10.1126/science.aay9189.
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Completamento primario (Stimato)
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Neoplasie genitali, maschio
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie
- Malattie genitali, maschio
- Malattie della prostata
- Malattie urogenitali maschili
- Neoplasie prostatiche
- Tecniche investigative
- Tecniche di laboratorio clinico
- Tecniche e procedure diagnostiche
- Diagnosi
- Tecniche citologiche
- Istocitochimica
- Tecniche istologiche
- Tecniche immunologiche
- Tecniche genetiche
- Tecniche di preparazione istocitologica
- Ibridazione in situ
- Colorazione ed etichettatura
- Analisi citogenetica
- Ibridazione degli acidi nucleici
- Immunoistochimica
- Ibridazione in situ, fluorescenza
- Fluorescent Antibody Technique
Altri numeri di identificazione dello studio
- KY2026-09-84
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .