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Molekylær profilering i vevsprøver fra pasienter med kreft som er eksepsjonelle respondere på behandling

10. november 2026 oppdatert av: National Cancer Institute (NCI)

Pilotstudie med eksepsjonelle respondere: Molekylær profilering av svulster fra kreftpasienter som er eksepsjonelle respondere

This pilot research trial studies molecular profiling in tissue samples from patients with cancer who got better with treatment that didn't work for most other patients with the same disease. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to how well patients respond to treatment.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

PRIMARY OBJECTIVES:

I. To identify molecular indicators in malignant tissues from patients who were exceptional responders on clinical trials or standard systemic treatments using whole exome and/or targeted deep sequencing, as well as potentially other sequencing and other molecular characterization methods (if adequate tissue exists).

II. To explore associations between the identified molecular indicators and the putative mechanism of action of the treatment received by the patient.

III. To test the feasibility of identifying "exceptional responders", obtaining the relevant tumor and normal tissue and clinical data, and performing whole exome and/or targeted deep sequencing on these samples.

OUTLINE:

Previously collected tissue samples are analyzed via whole exome sequencing and/or targeted next generation sequencing (NGS) assay deep sequencing. Cases for which sufficient nucleic acid amounts are available will undergo additional analyses including whole genome sequencing, messenger ribonucleic acid (RNA) (mRNA)-sequencing, micro (miRNA) sequencing, promoter methylation analysis, and single nucleotide polymorphism (SNP) analysis.

Studietype

Observasjonsmessig

Registrering (Faktiske)

170

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • California
      • Duarte, California, Forente stater, 91010
        • City of Hope Comprehensive Cancer Center
      • Fresno, California, Forente stater, 93720
        • Kaiser Permanente-Fresno
      • Oakland, California, Forente stater, 94611
        • Kaiser Permanente-Oakland
      • Richmond, California, Forente stater, 94801
        • Kaiser Permanente-Richmond
      • San Francisco, California, Forente stater, 94158
        • UCSF Medical Center-Mission Bay
      • Santa Clara, California, Forente stater, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Rosa, California, Forente stater, 95403
        • Kaiser Permanente-Santa Rosa
      • Stockton, California, Forente stater, 95210
        • Kaiser Permanente-Stockton
      • Walnut Creek, California, Forente stater, 94596
        • Kaiser Permanente-Walnut Creek
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • UCHealth University of Colorado Hospital
      • Fort Collins, Colorado, Forente stater, 80524
        • Poudre Valley Hospital
    • Connecticut
      • Greenwich, Connecticut, Forente stater, 06830
        • Greenwich Hospital
    • Delaware
      • Newark, Delaware, Forente stater, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, Forente stater, 19713
        • Medical Oncology Hematology Consultants PA
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20016
        • Sibley Memorial Hospital
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Columbus, Georgia, Forente stater, 31904
        • John B Amos Cancer Center
      • Valdosta, Georgia, Forente stater, 31602
        • South Georgia Medical Center/Pearlman Cancer Center
    • Idaho
      • Boise, Idaho, Forente stater, 83706
        • Saint Alphonsus Cancer Care Center-Boise
    • Illinois
      • Chicago, Illinois, Forente stater, 60631
        • Presence Resurrection Medical Center
      • Chicago, Illinois, Forente stater, 60612
        • Rush MD Anderson Cancer Center
      • Decatur, Illinois, Forente stater, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, Forente stater, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Evanston, Illinois, Forente stater, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Peoria, Illinois, Forente stater, 61615
        • Illinois CancerCare-Peoria
      • Springfield, Illinois, Forente stater, 62702
        • Springfield Clinic
    • Iowa
      • Cedar Rapids, Iowa, Forente stater, 52402
        • Physicians' Clinic of Iowa PC
    • Maine
      • York Village, Maine, Forente stater, 03909
        • York Hospital
    • Maryland
      • Bethesda, Maryland, Forente stater, 20892
        • NCI - Center for Cancer Research
      • Bethesda, Maryland, Forente stater, 20892
        • National Cancer Institute Developmental Therapeutics Clinic
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan Rogel Cancer Center
      • Ann Arbor, Michigan, Forente stater, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Brighton, Michigan, Forente stater, 48114
        • Trinity Health Medical Center - Brighton
      • Detroit, Michigan, Forente stater, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Grand Rapids, Michigan, Forente stater, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Marquette, Michigan, Forente stater, 49855
        • UP Health System Marquette
      • Marquette, Michigan, Forente stater, 49855
        • UP Health System Hematology Oncology Marquette
      • Southfield, Michigan, Forente stater, 48075
        • Henry Ford Health Providence Southfield Hospital
    • Missouri
      • Cape Girardeau, Missouri, Forente stater, 63703
        • Saint Francis Medical Center
      • Springfield, Missouri, Forente stater, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Forente stater, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Forente stater, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, Forente stater, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, Forente stater, 63141
        • Mercy Hospital Saint Louis
    • Montana
      • Great Falls, Montana, Forente stater, 59405
        • Benefis Sletten Cancer Institute
    • New Hampshire
      • Portsmouth, New Hampshire, Forente stater, 03802
        • Portsmouth Regional Hospital
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87106
        • University of New Mexico Cancer Center
    • New York
      • Rochester, New York, Forente stater, 14642
        • University of Rochester
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, Forente stater, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Fargo, North Dakota, Forente stater, 58122
        • Sanford Roger Maris Cancer Center
    • Ohio
      • Columbus, Ohio, Forente stater, 43214
        • Riverside Methodist Hospital
    • Oklahoma
      • Lawton, Oklahoma, Forente stater, 73505
        • Cancer Centers of Southwest Oklahoma Research
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, Forente stater, 97227
        • Kaiser Permanente Northwest
    • Pennsylvania
      • Phoenixville, Pennsylvania, Forente stater, 19460
        • Reading Hospital McGlinn Cancer Institute at Phoenixville
      • West Chester, Pennsylvania, Forente stater, 19380
        • Chester County Hospital
      • West Reading, Pennsylvania, Forente stater, 19611
        • Reading Hospital
    • South Carolina
      • Greenville, South Carolina, Forente stater, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, Forente stater, 29605
        • Prisma Health Cancer Institute - Butternut
      • Seneca, South Carolina, Forente stater, 29672
        • Prisma Health Cancer Institute - Seneca
    • South Dakota
      • Sioux Falls, South Dakota, Forente stater, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, Forente stater, 57104
        • Sanford Cancer Center Oncology Clinic
    • Tennessee
      • Kingsport, Tennessee, Forente stater, 37660
        • Wellmont Holston Valley Hospital and Medical Center
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
      • Houston, Texas, Forente stater, 77030
        • Ben Taub General Hospital
      • San Antonio, Texas, Forente stater, 78229
        • University of Texas Health Science Center at San Antonio
    • Utah
      • Salt Lake City, Utah, Forente stater, 84112
        • Huntsman Cancer Institute/University of Utah
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22908
        • University of Virginia Cancer Center
    • West Virginia
      • Martinsburg, West Virginia, Forente stater, 25401
        • WVUH-Berkely Medical Center
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Summit, Wisconsin, Forente stater, 53066
        • Aurora Medical Center in Summit
      • Waukesha, Wisconsin, Forente stater, 53188
        • UW Cancer Center at ProHealth Care

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients with cancer participating in the Exceptional Cases Initiative

Beskrivelse

Inclusion Criteria:

  • Documented exceptional response, defined as patients meeting the following criteria:

    • Complete response to a regimen in which complete response is expected in < 10% of similarly treated patients

    • Partial response (PR) > 6 months in a regimen in which PRs > 6 months are expected in < 10% of patients with similar disease treated with same or similar regimen

    • Complete response (CR) or PR of unusual duration, such that the internal review committee considers it to be an exceptional response; examples below:

      • PR of duration > 3 x the median expected PR duration (in cases where PR is expected in > 10% of patients with the same disease treated with the same regimen)
      • CR or duration > 3 x the median expected CR duration (in cases where CR may be seen in > 10% of patients with same disease treated with same regimen)
      • The observed duration of CR (or PR) is longer than expected for 90% of patients with same disease treated with same regimen

    • Note: it is not required that the patient be enrolled on a clinical trial when the exceptional response was observed

  • Reports of radiologic scans or other evidence documenting response will be submitted for review; cases where response is not assessable (e.g. adjuvant treatment) will not be eligible because the outcome can not be attributed to a specific treatment

  • Treatment history must be available, for prior treatment and for the drug to which the exceptional response occurred

  • Patient must meet consent criteria; this requires: (i) current exceptional responder (ER) consent by a living participant not lost to follow-up, (ii) prior consent for future research by a participant not known to be deceased, but lost to follow-up, or (iii) if patient is deceased and did not decline to participate in research at the time of tissue removal for any tissue that would be used in this study, then no consent is required

  • Tumor sample available that meets study requirements

  • Required tumor samples MUST exist and be able to be submitted; investigators wishing to submit samples must not have made agreements that would prohibit the free use of data from such samples; the National Cancer Institute (NCI) will provide investigators with a letter for the collaborator amending their existing agreement to allow for the case to be submitted

    • Tumor tissue from prior to administration of the drug to which the exceptional response occurred is required; ideally this sample will have been collected just prior to treatment, but other prior tissue will be considered; tissue may be fresh frozen or formalin-fixed paraffin embedded
    • Tumor tissue amount must be at least a core biopsy, and meet minimum specimen requirements

  • Encouraged: normal tissue sample: (optional): blood or other specimen source for germline sequencing

  • The tumor samples and clinical data submitted to the Exceptional Responders Database in database in Genotypes and Phenotypes (dbGaP) will need to have appropriate agreements in place to allow for the submission; the Exceptional Responders Database can accept clinical data and samples from cases enrolled on a Cancer Therapy Evaluation Program (CTEP) sponsored clinical trial and cases that were not enrolled on any clinical trial; if the response occurred on a trial that was not CTEP-sponsored, there are existing agreements between the submitting site and the pharmaceutical company; if existing agreements do not allow for the submission of sample and clinical data, the NCI will provide the investigators with a letter that allows the tissue to be used for the exceptional responders study if signed by the appropriate collaborator; the letter modifies the existing agreement to include the CTEP Intellectual Property (IP) Option language that would allow the case to be submitted to the Exceptional Responders Database; if the existing agreement cannot be modified and the letter cannot be signed, the proposed case will not be accepted; Note: as stated above, the patient does not need to have been enrolled on a clinical trial to be eligible for the exceptional responders study

Exclusion Criteria:

  • Patient's response did not meet criteria for an exceptional response
  • Patient's treatment regimen is expected to lead to CR or durable PR in > 10% of patients
  • Patient's duration of response is not > 3 x expected median length of response
  • Response not evaluable or not able to be attributed to systemic treatment (e.g. adjuvant treatment)
  • Patient refused consent for use of tissue for research activities included in the exceptional responders study
  • Tumor sample from prior to the exceptional response is not available, or does not meet quality metrics

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: CASE_CONTROL
  • Tidsperspektiver: RETROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Ancillary-Correlative (molecular profiling)

Previously collected tissue samples are analyzed via whole exome sequencing and/or targeted NGS assay deep sequencing. Cases for which sufficient nucleic acid amounts are available will undergo additional analyses including whole genome sequencing, mRNA-sequencing, miRNA sequencing, promoter methylation analysis, and SNP analysis.
Annen: Laboratory Biomarker Analysis

Undergo sequencing and SNP analysis

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Molecular features in tissue samples from patients who were exceptional responders
Tidsramme: Baseline

The molecular features of the tumors in the patients will be discernible as distinct to the tumor by comparison to (i) samples from normal tissue in the same patient and (ii) databases of similar data for normal and other tumor types.
Baseline
Putative mechanisms of action of the treatments that the patients received when they experienced their exceptional responses
Tidsramme: Baseline

The associations between identified molecular features and the putative mechanisms of action of the treatments that the patients received when they experienced their exceptional responses will be explored. Statistical analyses will be primarily descriptive.
Baseline
Number of cases identified as potential exceptional responders
Tidsramme: Baseline

Statistical analyses will be primarily descriptive.
Baseline
Percentage of identified potential cases confirmed to be exceptional responders
Tidsramme: Baseline

Statistical analyses will be primarily descriptive.
Baseline
Percentage of confirmed exceptional responders for which adequate tissue with appropriate informed consent is acquired
Tidsramme: Baseline

Statistical analyses will be primarily descriptive.
Baseline
Percentage of acquired cases with tissue for which at least the minimum molecular characterization is successfully obtained
Tidsramme: Baseline

Statistical analyses will be primarily descriptive.
Baseline
Percentage of molecularly characterized cases for which a Molecular Characterization report identified (without reference to the drug received by the patient) at least one feature judged to have potential therapeutic relevance
Tidsramme: Baseline

Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by an expert panel ("Panel") to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals.
Baseline
Percentage of cases with >= 1 feature on Molecular Characterization report that was judged to have potential therapeutic relevance to the specific class of drug the patient actually received when the exceptional response was experienced
Tidsramme: Baseline

Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by the Panel to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals.
Baseline
Percentage of cases with >= 1 feature that correlates with the mechanism of action of the specific grant to which the exceptional response occurred that was found after further analyzing the molecular profile data for relevant molecular abnormalities
Tidsramme: Baseline

Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by the Panel to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals.
Baseline

Samarbeidspartnere og etterforskere

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

Sponsor

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: S. P Ivy, National Cancer Institute (NCI)

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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)

24. september 2014

Primær fullføring (Faktiske)

4. mars 2021

Studiet fullført (Antatt)

30. april 2027

Datoer for studieregistrering

Først innsendt

16. september 2014

Først innsendt som oppfylte QC-kriteriene

16. september 2014

Først lagt ut (Antatt)

18. september 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. november 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NCI-2014-01585
  • UM1CA186704 (U.S. NIH-stipend/kontrakt)
  • 9671 (Annen identifikator: CTEP)
  • NCI-2014-01585 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • 9671 (Annen identifikator: National Cancer Institute)

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. .

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