Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Blood Test for Early Detection of Breast Cancer Using Todos Medical -Breast 1(TM-B1) Assay (TM-B1)

20. august 2018 oppdatert av: Todos Medical, Ltd.
Blood samples from a total of 200 women in two cohorts will be collected and analyzed by TM-B1 assay, which is based on TBIA (Total Biochemical Infrared Analysis) to confirm the presence of cancer. These two cohorts will yield 75 healthy women with no pathological findings, 75 women diagnosed as having benign breast tumor and 50 women diagnosed as having breast cancer.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Prospective, two arms, observational, blinded, cohort study enrolling 200 women which intended to validate the cut-off points between women with malignant tumors, benign tumors, and women without tumors (controls) and to validate the sensitivity and specificity of TM-B1 for the detection of an invasive breast tumor.

Two cohorts will be tested with TM-B1. The cohorts will differ in the percentage of women that are expected to yield a positive finding for breast cancer. Any finding in TM-B1 will not influence medical standards of care.

Studietype

Observasjonsmessig

Registrering (Forventet)

200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Israel
      • Rehovot, Israel, 76100
        • Rekruttering
        • Kaplan Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tanir Alweis, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

25 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Cohort 1: Screening Population - Women presenting for routine XRM and / or breast US.

Cohort 2: Breast Cancer Population - Women who were diagnosed with malignant breast tumors, as determined by biopsy, and have not yet begun any treatment for the disease.

Beskrivelse

Inclusion Criteria:

Screening Population:

  • Subject signed the informed consent.
  • Subject is aged 25 years and older.
  • Subject is presenting for routine screening or diagnostic XRM and / or breast US.

Breast Cancer Population

  • Subject signed the informed consent form.
  • Subject is aged 25 years and older.
  • Subject was diagnosed with a malignant breast tumor, and has not yet started treatment.

Exclusion Criteria:

All Subjects:

  • Subject has been diagnosed with any type of malignancy apart from breast cancer.
  • Subject has been previously treated for breast cancer.
  • Subject underwent any surgery within the previous year (apart from benign nevus removal).
  • Subject was treated for benign tumor within the previous year (e.g. polyps or cysts).
  • Subject has an active infection or inflammation from any type of infection (bacterial or viral) as determined clinically at screening.
  • Subject is currently taking medications related directly to, or that can affect, the immune system such as steroids.
  • Subject has any type of active autoimmune disease such as lupus or rheumatoid arthritis.
  • Diagnostic drugs (e.g. contrast materials) were injected or given orally to subject within the last 7 days prior to sample collection for TM-B1 analysis.
  • Subject has been taking any investigational drug which influence her health status within 30 days prior to sample collection for TM-B1 analysis.
  • Subject is not feeling well at the time of blood collection for TM-B1 analysis due to suspected bacterial or viral infection or subject has symptoms such as high fever, diarrhea, headache, vomiting, dizziness etc.
  • Subject is pregnant, lactating, or undergoing fertility treatment.
  • Subject has participated in this study, in another cohort, and the TM-B1 test was performed.

Breast Cancer Population only:

  • The subject's tumor has been surgically removed before sample collection for TM-B1 analysis.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Screening Population

Cohort 1:Screening Population - Women presenting for routine XRM and / or breast US.

Participants will be followed for one year and the outcome of those who undergo an annual XRM / breast ultrasound will be recorded.
Diagnostisk test: Screening Population
Blood samples taken from screening population
Breast Cancer Population
Cohort 2:Breast Cancer Population - Women who were diagnosed with malignant breast tumors, as determined by biopsy, and have not yet begun any treatment for the disease.
Diagnostisk test: Breast Cancer Population
Blood samples taken from Breast Cancer population

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
This study is intended to evaluate the sensitivity and specificity of the TM-B1 test compared to the Gold Standard diagnostic methods and clinical evaluations based on Digital X-Ray Mammography (XRM), and / or ultrasound, and / or MRI and / or pathology.
Tidsramme: Timepoint 1, day 1
the subject's blood (Groups 1 and 2)will be tested for the presence of breast cancer
Timepoint 1, day 1

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
For asymptomatic women who have dense breast tissue (parenchymal density > 50% on XRM), evaluate the performance, in terms of sensitivity and specificity, of the TM-B1 test and XRM together as a breast cancer screening procedure compared to the XRM alone
Tidsramme: Timepoint one, day 1
The subject's blood (Groups 1 and 2) will be tested for the presence of breast cancer
Timepoint one, day 1

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Todos Medical, Ltd.

Etterforskere

  • Hovedetterforsker: Tanir N Alweis, M.D., Kaplan Medical Center,Pasternak St., POB 1, Rehovot 76100, Israel

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. januar 2018

Primær fullføring (Forventet)

1. mai 2019

Studiet fullført (Forventet)

1. juli 2019

Datoer for studieregistrering

Først innsendt

12. november 2017

Først innsendt som oppfylte QC-kriteriene

12. november 2017

Først lagt ut (Faktiske)

17. november 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. august 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. august 2018

Sist bekreftet

1. august 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IL-TM-B1-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Brystkreft

Kliniske studier på Screening Population

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in India

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere