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Clinical Trials in Mexico / NCT02243592
Active, not recruiting Observational

Molecular Profiling in Tissue Samples From Patients With Cancer Who Are Exceptional Responders to Treatment

NCT02243592 · tracked via the Priya Life Science Mexico tracker
Phase
Observational
Started
2014-09-24
Last updated
2026-04-17

Condition(s) studied

Malignant Neoplasm

Investigational drug(s) / intervention(s)

Laboratory Biomarker Analysis

Laboratory Biomarker Analysis: Undergo sequencing and SNP analysis

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (73)

FacilityCityRegionStatus
City of Hope Comprehensive Cancer Center Duarte California
Kaiser Permanente-Fresno Fresno California
Kaiser Permanente-Oakland Oakland California
Kaiser Permanente-Richmond Richmond California
UCSF Medical Center-Mission Bay San Francisco California
Kaiser Permanente Medical Center - Santa Clara Santa Clara California
Kaiser Permanente-Santa Rosa Santa Rosa California
Kaiser Permanente-Stockton Stockton California
Kaiser Permanente-Walnut Creek Walnut Creek California
UCHealth University of Colorado Hospital Aurora Colorado
Poudre Valley Hospital Fort Collins Colorado
Greenwich Hospital Greenwich Connecticut
Helen F Graham Cancer Center Newark Delaware
Medical Oncology Hematology Consultants PA Newark Delaware
Sibley Memorial Hospital Washington D.C. District of Columbia
Emory University Hospital/Winship Cancer Institute Atlanta Georgia
John B Amos Cancer Center Columbus Georgia
South Georgia Medical Center/Pearlman Cancer Center Valdosta Georgia
Saint Alphonsus Cancer Care Center-Boise Boise Idaho
Rush MD Anderson Cancer Center Chicago Illinois
Presence Resurrection Medical Center Chicago Illinois
Cancer Care Specialists of Illinois - Decatur Decatur Illinois
Decatur Memorial Hospital Decatur Illinois
NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
Illinois CancerCare-Peoria Peoria Illinois
Springfield Clinic Springfield Illinois
Physicians' Clinic of Iowa PC Cedar Rapids Iowa
York Hospital York Village Maine
National Cancer Institute Developmental Therapeutics Clinic Bethesda Maryland
NCI - Center for Cancer Research Bethesda Maryland
Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
University of Michigan Rogel Cancer Center Ann Arbor Michigan
Trinity Health Medical Center - Brighton Brighton Michigan
Wayne State University/Karmanos Cancer Institute Detroit Michigan
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan
UP Health System Hematology Oncology Marquette Marquette Michigan
UP Health System Marquette Marquette Michigan
Henry Ford Health Providence Southfield Hospital Southfield Michigan
Saint Francis Medical Center Cape Girardeau Missouri
Mercy Hospital Springfield Springfield Missouri

+ 33 more sites — see the full list on the official registry below.

More National Cancer Institute (NCI) trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02243592 on ClinicalTrials.gov ↗ ← All trials in Mexico