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Immunogenic Cell Death as a Novel Mechanism of Mitomycin C Activity in Bladder Cancer (ICH-MIM-01)

4. juli 2020 opdateret af: Michele Tedeschi, Istituto Clinico Humanitas
The principal objective of this study consists in the assessment of Immunogenic Cell Death (ICD) induction in neoplastic tissues derived from bladder cancer patients treated ex vivo with Mitomycin C (MMC). The evaluation is performed using cellular and molecular analyses of treated versus untreated samples derived from the same patient

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Urothelial or transitional cell carcinoma of the bladder is the fourth most common cancer in males worldwide, with about 60-80% of newly diagnosed patients having non-muscle-invasive bladder cancer (NMIBC). NMIBC management consist in transurethral resection of bladder tumor (TURBT) followed by adjuvant intravesical treatment with the chemotherapeutic agent Mitomycin C (MMC) or the immunotherapy bacillus Calmette-Guérin. These therapies result in low progression rates, but are not efficacious in all patients, leading to high tumor recurrence. Immunogenic cell death (ICD) may be one of the mechanisms of action of MMC intravesical therapy in bladder cancer.

The primary objective of the study is to evaluate whether MMC is able to trigger ICD in patient-derived neoplastic tissues. As secondary targets we aim to:

  1. identify an expression profile that is common to all tumors that undergo ICD upon MMC treatment ('ICD signature'),
  2. asses the genetic and environmental factors- urinary microbiome composition- responsible for MMC treatment efficacy,
  3. evaluate whether ICD induction correlates with clinical staging and response (clinical endpoints for MMC-treated patients are recurrence at three month and one year after enrollment).

Undersøgelsestype

Observationel

Tilmelding (Forventet)

110

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Italien
    • Milan
      • Rozzano, Milan, Italien, 20089
        • Rekruttering
        • Humanitas reseach hospital (ICH)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

80 patients with carcinoma of the bladder; divided in 20 patients Ta (low grade), 20 patients Ta/T1 (high grade) and 20 patients T2. Only for liquid samples collection we will include 20 CIS (carcinoma in situ) patients.

30 age and sex-matched subjects not suffering from carcinoma of the bladder, already hospitalized in ICH; we expect to enroll 24 males and 6 females of which 10 of 40- 60 years old, 10 of 60-70 years old, 10 of >70 years old.

Beskrivelse

Inclusion Criteria:

- Male and females, > 40 years old

For bladder cancer patients:

- bladder cancer patients- patinets with first tumor occurrence or patient with a recurrence after more than 2 years from the removal of the prior malignancy

Exclusion Criteria:

  • Treated with immunomodulatory agents at time of enrollment or in the two months before enrollment
  • Treated with antibiotics at time of enrollment or during the month before enrollment
  • Positive history of sexually transmitted diseases
  • Urinary infection ongoing or recent (during the three months before enrollment)
  • Suffering from chronic intestinal inflammation

ONLY for controls:

  • Treated with immunomodulatory agents at time of enrollment or in the two months before enrollment
  • Treated with antibiotics at time of enrollment or during the month before enrollment
  • Positive history of sexually transmitted diseases
  • Urinary infection ongoing or recent (during the three months before enrollment)
  • Suffering from chronic intestinal inflammation

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Bladder cancer patients
80 patients with carcinoma of the bladder; divided in 20 patients Ta (low grade), 20 patients Ta/T1 (high grade) and 20 patients T2. Only for liquid samples collection we will include 20 CIS (carcinoma in situ) patients
Andet: This is an observational study that does not concern a direct intervention on patients and control subjects and does not interfere with the clinical management of patients.

urine collection: DNA is isolated from urine samples (catheterized, washout, midstream) and the 16S rRNA gene is sequenced.

Specimen collection: Specimens collected during TURBT are selected by a pathologist and trasferred to the laboratory. The tissues are treated ex vivo with MMC.
Controls- Healthy subjects
30 age and sex-matched subjects not suffering from carcinoma of the bladder, already hospitalized in ICH; we expect to enroll 24 males and 6 females of which 10 of 40- 60 years old, 10 of 60-70 years old, 10 of >70 years old.
Andet: This is an observational study that does not concern a direct intervention on patients and control subjects and does not interfere with the clinical management of patients.

urine collection: DNA is isolated from urine samples (catheterized, washout, midstream) and the 16S rRNA gene is sequenced.

Specimen collection: Specimens collected during TURBT are selected by a pathologist and trasferred to the laboratory. The tissues are treated ex vivo with MMC.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
MMC-induced ICD
Tidsramme: 3 years
The main aim of this study is to evaluate whether MMC is able to trigger ICD in patient-derived neoplastic tissues.
3 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ICD signature analyzed by RNAseq analysis
Tidsramme: 3 years
Identify an expression profile that is common to all tumors that undergo ICD upon MMC treatment ('ICD signature')
3 years
Microbiota study
Tidsramme: 3 years
Verify the existance of urinary microbiome using catheterized urines and identify changes in urinary microbiome composition correlating with bldder cancer, MMC efficacy and staging/progression of the disease
3 years

Samarbejdspartnere og efterforskere

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Sponsor

Istituto Clinico Humanitas

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. juni 2018

Primær færdiggørelse (Forventet)

1. september 2020

Studieafslutning (Forventet)

30. september 2020

Datoer for studieregistrering

Først indsendt

3. februar 2020

Først indsendt, der opfyldte QC-kriterier

3. februar 2020

Først opslået (Faktiske)

5. februar 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juli 2020

Sidst verificeret

1. juli 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2041

Plan for individuelle deltagerdata (IPD)

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INGEN

IPD-planbeskrivelse

Research outcome

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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