Molecular Profiling in Tissue Samples From Patients With Cancer Who Are Exceptional Responders to Treatment
NCT ID: NCT02243592
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
170 participants
OBSERVATIONAL
2014-09-24
2026-04-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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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.
Laboratory Biomarker Analysis
Undergo sequencing and SNP analysis
Interventions
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Laboratory Biomarker Analysis
Undergo sequencing and SNP analysis
Eligibility Criteria
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Inclusion 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 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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S. P Ivy
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Kaiser Permanente-Fresno
Fresno, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Kaiser Permanente-Richmond
Richmond, California, United States
UCSF Medical Center-Mission Bay
San Francisco, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States
Kaiser Permanente-Stockton
Stockton, California, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Greenwich Hospital
Greenwich, Connecticut, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
John B Amos Cancer Center
Columbus, Georgia, United States
South Georgia Medical Center/Pearlman Cancer Center
Valdosta, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, United States
Presence Resurrection Medical Center
Chicago, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, United States
York Hospital
York Village, Maine, United States
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, Maryland, United States
NCI - Center for Cancer Research
Bethesda, Maryland, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States
UP Health System Hematology Oncology Marquette
Marquette, Michigan, United States
UP Health System Marquette
Marquette, Michigan, United States
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Portsmouth Regional Hospital
Portsmouth, New Hampshire, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
University of Rochester
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Kaiser Permanente Northwest
Portland, Oregon, United States
Reading Hospital McGlinn Cancer Institute at Phoenixville
Phoenixville, Pennsylvania, United States
Chester County Hospital
West Chester, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
WVUH-Berkely Medical Center
Martinsburg, West Virginia, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Aurora Medical Center in Summit
Summit, Wisconsin, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States
Countries
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References
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Moore KN, Mannel RS. Is the NCI MATCH trial a match for gynecologic oncology? Gynecol Oncol. 2016 Jan;140(1):161-6. doi: 10.1016/j.ygyno.2015.11.003. Epub 2015 Nov 14.
Other Identifiers
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NCI-2014-01585
Identifier Type: REGISTRY
Identifier Source: secondary_id
9671
Identifier Type: OTHER
Identifier Source: secondary_id
9671
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2014-01585
Identifier Type: -
Identifier Source: org_study_id
NCT02496195
Identifier Type: -
Identifier Source: nct_alias
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