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Sample Collection for Ongoing Research and Product Evaluation Study - Non-muscle Invasive Bladder Cancer (SCORE-NMIBC) (SCORE-NMIBC)

9. august 2026 opdateret af: Natera, Inc.
The SCORE-NMIBC study is a prospective, multi-center, study designed to collect data and biological samples from participants diagnosed with non-muscle Invasive Bladder Cancer (NMIBC). Study participants will undergo research blood and urine collections, as well as tumor tissue collected as part of a standard-of-care procedure(s), for use in research. Collected samples and data will be analyzed to evaluate biomarkers associated with development and validation of cancer monitoring and detection assays ("Natera cancer monitoring and detection test(s)").

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

The study is designed to evaluate the clinical performance of Natera's molecular residual disease (MRD) assays in detecting ctDNA in patients diagnosed with NMIBC. The goal is to assess the ability of the assay to identify minimal residual disease, monitor disease recurrence, and evaluate treatment response on therapy. No individual test results from the study testing will be provided to participants or their treating clinicians.

Participants who meet the study eligibility criteria will be invited to enroll in the study. Informed consent form (ICF) (paper or electronic) will be signed by the participant prior to study procedures. Participants will provide study-specific blood and urine samples at protocol defined timepoints.

The SCORE-NMIBC study includes two participant cohorts:

Cohort A - Intravesical Therapy and/or Systemic Therapy Cohort B - Cystectomy

Participants may be followed for up to three years, including up to two years of blood and urine collection and up to one year of data-only follow-up.

Tissue Sample Collection:

Residual tissue samples, collected as part of standard-of-care procedures, will also be obtained for study purposes.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

400

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • Texas
      • Austin, Texas, Forenede Stater, 78753
        • Rekruttering
        • Natera, Inc.
        • Kontakt:
          • Adam ElNaggar, MD
          • Telefonnummer: 650-489-9050

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants 18 years of age or older diagnosed with Non-muscle Invasive Bladder Cancer (NMIBC) prior to receiving treatment.

Beskrivelse

Inclusion Criteria:

  1. Patient is at least 18 years of age or older.
  2. Eastern Cooperative Oncology Group performance status ≤ 2.

  3. Patient has a suspected high risk non-muscle invasive bladder cancer.

    Note: The AUA/SUO risk stratification for primary non-muscle invasive bladder cancer will be used to determine high risk of tumor progression based on clinic and pathologic prognostic factors (Holzbeierlein et al., 2024):

    1. High grade T1.
    2. Any recurrent, High-grade TA.
    3. High grade TA, >3 cm (or multifocal).
    4. BCG failure in high grade patient.

    5. Any variant histology.*

      *e.g. Micropapillary, plasmacytoid, small cell/neuroendocrine, and sarcomatoid histologies (in pure or mixed form with associated urothelial carcinoma)

    6. Any lymphovascular invasion.
    7. Any high grade prostatic urethral invasion.

  4. Meet the following criteria:

    a. Cohort A: i. Participant has high risk ≤ T1 bladder cancer and is eligible for intravesical therapy or cystectomy. ii. Participant has been treated with intravesical and/or systemic therapy for high risk ≤ T1 bladder cancer and is entering surveillance. b. Cohort B i. Participant has high risk ≤ T1 bladder cancer and undergoing primary treatment with cystectomy. ii. Patients undergoing cystectomy following recurrence or progression of high risk ≤ T1 bladder cancer and where ≤ T1 bladder cancer is confirmed on cystectomy surgical pathology.

  5. Willing and able to tolerate blood draws according to Natera standard process.
  6. Willing to provide urine collection samples.
  7. Able to consent to and provide residual tumor tissue for research.
  8. Willing and able to comply with the study requirements.

Exclusion Criteria:

  1. Pregnant or breastfeeding.
  2. Prior history and treatment for any cancer (including muscle invasive bladder cancer) within the past year, or if they have any other active cancer, with the exception of participants who have undergone surgical removal of basal or squamous skin cancers, as well as those who have received NMIBC-directed therapy, including those undergoing cystectomy for primary NMIBC or after recurrence/progression of NMIBC.
  3. Diagnosis of >T1 bladder cancer at time of enrollment.
  4. Tumor tissue unavailable and/or consists only of carcinoma in situ (CIS) disease.
  5. At time of enrollment, has undergone or plans to undergo any ctDNA or utDNA testing to assess MRD, with the exception of one-time comprehensive genomic profiling for therapeutic drug selection.
  6. History of bone marrow or organ transplant.
  7. Serious medical conditions that may adversely affect ability to participate in the study.

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
Cohort A - Intravesical Therapy
Samples collected at enrollment, before repeat TURBT (if done), then every 6 weeks during induction, then every 3 months for 2 years.
Cohort A - Systemic Therapy
Samples collected at enrollment, before repeat TURBT (if done), at treatment start, at first follow-up, then every 3 months for 2 years.
Cohort B - Cystectomy
Samples collected at enrollment, before repeat TURBT (if done), pre- and post-cystectomy (blood only post-op), then every 3 months for 2 years if NMIBC is confirmed on pathology.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Completed Participants with Blood, Urine and Residual Tissue Specimens Collected
Tidsramme: 3 Years
The primary outcome will be measured as the number of participants who complete collection of clinically characterized, de-identified whole blood, urine and residual tissue specimens. The planned number of completed participants is 225. The specimens and data will be used in development and validation of cancer monitoring and detection assays.
3 Years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Completed Participants with Blood, Urine and Residual Tissue Specimens Evaluated for Biomarkers
Tidsramme: 3 Years
The secondary outcome will be measured as the number of completed participants whose clinically characterized, de-identified whole blood, urine and residual tissue specimens are evaluated for biomarkers associated with the development and validation of disease assays. The planned number of completed participants is 225.
3 Years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Natera, Inc.

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 (Anslået)

27. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2032

Studieafslutning (Anslået)

1. juli 2032

Datoer for studieregistrering

Først indsendt

17. juli 2026

Først indsendt, der opfyldte QC-kriterier

9. august 2026

Først opslået (Faktiske)

13. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. august 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25-096-NCP

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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