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Molecular Determinants of Response to Preoperative Therapy in Patients With Locally Advanced Colorectal Cancer

24. maj 2019 opdateret af: M.D. Anderson Cancer Center

The goal of this laboratory research is to look for genes that can predict which patients will achieve a complete disappearance of their colorectal cancer after treatment like chemotherapy, radiation, or other therapy.

This is an investigational study. Up to 350 patients will take part in this study. All will be enrolled at MD Anderson.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients with colorectal cancer usually receive radiation, chemotherapy, or other therapy before they have surgery. At this time, there are no tests that can help researchers find out which patients no longer have any tumor left after completing treatment. Because of this, all patients have to have surgery to completely remove the rectum and/or part of the colon. This procedure results in lifestyle changes for the patient, which may be difficult and permanent.

Researchers are looking for new ways to find out which patients will have no tumor left after treatment, so that in the future, some patients may be able to avoid surgery altogether. In this study, researchers will try to use chemical "markers" in tumor cells as a way to possibly predict whether or not the tumor is likely to disappear with treatment alone.

At MD Anderson, all patients with colorectal cancer have an endoscopy performed by their surgeon as part of standard care, before they start therapy. Endoscopy involves placing a narrow tube in the colon and/or rectum in order to see and inspect the tumor.

If you choose to take part in this study, tissue samples will be taken from the tumor and the normal areas during your standard endoscopy. If you undergo surgery, tissue samples from the tumor(s) and normal areas will also be collected. At the time of endoscopy and/or surgery, once the doctor has finished all standard tests on this tissue and has received the clinical reports on these tests, any leftover tissue samples will be collected by Dr. You or a person on her research team for research tests to look for tumor cell "markers." Researchers want to find out how these markers may have changed since you began receiving treatment for the disease.

Some of the tissue from your biopsies may also be sent to the labs at University of Texas-Southwest or Natera for testing. No identifying information about you will be included with these samples. They will have a special number assigned, so that the samples being sent to UT Southwest or Natera will not be able to be connected to you in any way.

The results of these tests will not be used to make any decisions regarding treatment of your rectal cancer. There are no other tests or procedures required in this study

Undersøgelsestype

Observationel

Tilmelding (Forventet)

250

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Rekruttering
        • University of Texas MD Anderson Cancer Center

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants with Colorectal Cancer in the Gastrointestinal (GI) department at University of Texas MD Anderson Cancer Center.

Beskrivelse

Inclusion Criteria:

  1. Patients with colorectal adenocarcinoma (diagnosis based on either MDACC or outside records)
  2. Patients scheduled to undergo neoadjuvant therapy per MDACC care team.
  3. Patients over 18 years of age.
  4. Patients with distant organ findings deemed to be indeterminate or metastatic will be enrolled at the surgeon's discretion.
  5. Patients who have been deemed medically safe to undergo endoscopic biopsy by the physician performing the procedure.
  6. Patients who would have typically undergone preoperative therapy followed by surgery but for specific reasons at the discretion of the treating physician underwent surgery without preoperative therapy may be enrolled at the surgeons' discretion.

Exclusion Criteria:

N/A

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
Colorectal Cancer
Participants undergo standard endoscopy before therapy. Tissue samples taken from the tumor and normal colorectal tissue.
Procedure: Endoscopy
Tissue samples taken from tumor and normal colorectal tissue during standard endoscopy before therapy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Predictive Tumor Cell Biomarkers After Chemoradiation Treatment for Colorectal Cancer
Tidsramme: 1 day
Tissue taken at endoscopy undergoes testing for tumor cell biomarkers to identify patients who achieve complete response (CR).
1 day

Samarbejdspartnere og efterforskere

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

Sponsor

M.D. Anderson Cancer Center

Samarbejdspartnere

Research Foundation of the American Society of Colon and Rectal Surgeons

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.

Hjælpsomme links

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)

1. august 2005

Primær færdiggørelse (Forventet)

1. august 2022

Studieafslutning (Forventet)

1. august 2023

Datoer for studieregistrering

Først indsendt

17. august 2016

Først indsendt, der opfyldte QC-kriterier

19. august 2016

Først opslået (Skøn)

24. august 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. maj 2019

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LAB04-0962
  • R33 CA118505-01 (Andet bevillings-/finansieringsnummer: American Society of Colon and Rectal Surgeons Research)

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 .

Kliniske forsøg med Kolorektal cancer

Kliniske forsøg med Endoscopy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Djibouti

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
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