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Cancer mystery solved? study probes 'Exceptional Responders' for genetic secrets

NCT ID NCT02243592

Knowledge-focused Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study examines tumor tissue from 170 cancer patients who had unusually good responses to treatments that failed for most others. Researchers will analyze the DNA of these tumors to find genetic changes that might explain why these patients did so well. The goal is to discover biomarkers that could help predict which treatments work best for future patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

170 people

The number who actually took part.

Started

Sep 2014

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with cancer participating in the Exceptional Cases Initiative

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cancer neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malignant neoplasm

Contacts and locations

Locations

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066, United States

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030, United States

  • Ben Taub General Hospital

    Houston, Texas, 77030, United States

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405, United States

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526, United States

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505, United States

  • Chester County Hospital

    West Chester, Pennsylvania, 19380, United States

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503, United States

  • CoxHealth South Hospital

    Springfield, Missouri, 65807, United States

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Greenwich Hospital

    Greenwich, Connecticut, 06830, United States

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713, United States

  • Henry Ford Health Providence Southfield Hospital

    Southfield, Michigan, 48075, United States

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112, United States

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615, United States

  • John B Amos Cancer Center

    Columbus, Georgia, 31904, United States

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051, United States

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227, United States

  • Kaiser Permanente-Fresno

    Fresno, California, 93720, United States

  • Kaiser Permanente-Oakland

    Oakland, California, 94611, United States

  • Kaiser Permanente-Richmond

    Richmond, California, 94801, United States

  • Kaiser Permanente-Santa Rosa

    Santa Rosa, California, 95403, United States

  • Kaiser Permanente-Stockton

    Stockton, California, 95210, United States

  • Kaiser Permanente-Walnut Creek

    Walnut Creek, California, 94596, United States

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713, United States

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141, United States

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804, United States

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131, United States

  • NCI - Center for Cancer Research

    Bethesda, Maryland, 20892, United States

  • National Cancer Institute Developmental Therapeutics Clinic

    Bethesda, Maryland, 20892, United States

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201, United States

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52402, United States

  • Portsmouth Regional Hospital

    Portsmouth, New Hampshire, 03802, United States

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524, United States

  • Presence Resurrection Medical Center

    Chicago, Illinois, 60631, United States

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605, United States

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605, United States

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672, United States

  • Reading Hospital

    West Reading, Pennsylvania, 19611, United States

  • Reading Hospital McGlinn Cancer Institute at Phoenixville

    Phoenixville, Pennsylvania, 19460, United States

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214, United States

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612, United States

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706, United States

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703, United States

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104, United States

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122, United States

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134, United States

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016, United States

  • South Georgia Medical Center/Pearlman Cancer Center

    Valdosta, Georgia, 31602, United States

  • Springfield Clinic

    Springfield, Illinois, 62702, United States

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114, United States

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106, United States

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045, United States

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158, United States

  • UP Health System Hematology Oncology Marquette

    Marquette, Michigan, 49855, United States

  • UP Health System Marquette

    Marquette, Michigan, 49855, United States

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188, United States

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908, United States

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792, United States

  • WVUH-Berkely Medical Center

    Martinsburg, West Virginia, 25401, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660, United States

  • York Hospital

    York Village, Maine, 03909, United States

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