Breast Cancer Clinical Trial
Genetic Analysis of Blood and Tissue Samples From Patients With Advanced Cancer, Moonshot Study
Summary
This trial studies the genetic analysis of blood and tissue samples from patients with cancer that has spread to other anatomic sites (advanced) or is no longer responding to treatment. Studying these samples in the laboratory may help doctors to learn how genes affect cancer and how they affect a person's response to treatment.
Full Description
PRIMARY OBJECTIVES:
I. To procure paired newly acquired tumor tissues and blood at baseline and upon progression in patients treated for advanced cancer with molecularly targeted therapies at National Cancer Institute Community Oncology Research Program (NCORP) sites.
II. To bank formalin-fixed, paraffin-embedded (FFPE) tissue, blood (for cell-free deoxyribonucleic acid [DNA] analysis), and nucleic acids from patients in the Biorepository, which is the Biopathology Center (BPC) at Nationwide Children's Hospital (NCH), that may be used to study mechanisms of sensitivity and resistance to cancer therapies.
III. To bank, when available, optional snap-frozen tissue (for future to be determined analysis) from patients in the Biorepository, which is the Biopathology Center (BPC) at Nationwide Children's Hospital (NCH), that may be used to study mechanisms of sensitivity and resistance to cancer therapies.
IV. To assess the feasibility of obtaining paired high-quality newly acquired tumor tissues and blood from patients being treated for advanced cancer in community-based healthcare settings (NCORP sites).
SECONDARY OBJECTIVES:
I. To perform molecular profiling assays on matched malignant tumor and blood (including but not limited to whole exome and messenger ribonucleic acid [RNA] sequencing) in order to provide physicians and patients with a clinical report from a Clinical Laboratory Improvement Act (CLIA)-certified laboratory from tumor obtained at baseline and upon progression that may be used to guide further treatment planning.
II. To make available biospecimens for studies to define potential resistance biomarkers using genomic and proteomic-based assessment platforms.
III. To contribute genetic analysis data from coded specimens to Genomic Data Commons, a well annotated cancer molecular and clinical data repository, for current and future research; specimens will be annotated with key clinical data including presentation, diagnosis, staging, summary treatment, and outcome, if possible.
IV. To identify potential predictive and prognostic biomarkers beyond any genomic alteration by which treatment may be assigned.
V. To identify resistance mechanisms using genomic DNA- and RNA-based assessment platforms.
OUTLINE:
Patients undergo collection of blood and tumor prior to starting treatment and upon disease progression (second collection of blood and tumor only for patients who do not continue to progress and achieve either an objective response [OR] or stable disease [SD] after 6 months of treatment). Samples are banked and analyzed via next generation sequencing.
Eligibility Criteria
Inclusion Criteria:
Patient meets all eligibility criteria for treatment of the tumors with the agents listed and has agreed to provide tissue and blood samples for this study
Targeted therapy maybe as a singular/monotherapy or in combination with any Food and Drug Administration (FDA)-approved chemotherapies
Patient's primary or recurrent disease is targeted-treatment naive or will be treated with a targeted therapy listed different from any previously-received targeted therapy or combination therapy as standard of care
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. Patients with a PS of 2 may be enrolled only at the discretion of the treating physician and radiologist
Have an advanced malignancy being treated with one of the agents listed. Advanced cancer is cancer that is unlikely to be cured or controlled with treatment. The cancer may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body. Treatment may be given to help shrink the tumor, slow the growth of cancer cells, or relieve symptoms. Patients may be undergoing first or subsequent lines of therapy. In the case where an agent not listed is newly approved for one of the listed tumors, patients undergoing therapy with it will be able to enroll at discretion of the principal investigator (PI). This is to avoid any lag between FDA approval of a previously investigational agent and protocol modifications/updates
Have an advanced malignancy that meets one of the following criteria:
Patients must have tumor amenable to image guided or direct vision biopsy and be willing and able to undergo a tumor biopsy for molecular profiling. The biopsy must not be associated with a significant risk of severe or major complications or death. In particular, endoscopic, open or laparoscopic surgical procedures are not to be performed to provide research specimens. However, research specimens may be provided if the patient needs to undergo such procedures for clinical reasons
Severe or major complications are considered to be those
Requiring therapy, minor hospitalization (more than overnight but < 48 hours [h])
Requiring major therapy; unplanned increase in level of care, prolonged hospitalization > 48 h
Resulting in permanent adverse sequelae
Resulting in death
Patient will be undergoing a procedure due to medical necessity during which the tissue may be collected. The following tumors may be collected only under the conditions specified and not for the sole purpose of the clinical trial:
Brain biopsies: ONLY if the patient has medical necessity for craniotomy for clinical care
Mediastinal, laparoscopic, gastrointestinal, or bronchial endoscopic biopsies: ONLY to be obtained incidentally to a clinically necessary procedure
Exclusion Criteria:
Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy
Patients currently enrolled or planning to be co-enrolled (while participating on the 10231 study) on a therapeutically interventional clinical trial aimed to treat the current malignancy
If the patient is on chronic anticoagulation treatment, they must be able and willing to have this treatment discontinued for the biopsy. Discontinuation procedures will be those of the treating site
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There are 104 Locations for this study
Fort Lauderdale Florida, 33308, United States
Savannah Georgia, 31405, United States
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96826, United States
Lihue Hawaii, 96766, United States
Bloomington Illinois, 61704, United States
Canton Illinois, 61520, United States
Carbondale Illinois, 62902, United States
Carterville Illinois, 62918, United States
Carthage Illinois, 62321, United States
Centralia Illinois, 62801, United States
Decatur Illinois, 62526, United States
Decatur Illinois, 62526, United States
Dixon Illinois, 61021, United States
Effingham Illinois, 62401, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
O'Fallon Illinois, 62269, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peru Illinois, 61354, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62781, United States
Swansea Illinois, 62226, United States
Cedar Rapids Iowa, 52402, United States
Cedar Rapids Iowa, 52403, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50316, United States
West Des Moines Iowa, 50266, United States
Metairie Louisiana, 70006, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
Springfield Massachusetts, 01104, United States
Ann Arbor Michigan, 48106, United States
Brighton Michigan, 48114, United States
Brighton Michigan, 48114, United States
Canton Michigan, 48188, United States
Canton Michigan, 48188, United States
Caro Michigan, 48723, United States
Chelsea Michigan, 48118, United States
Chelsea Michigan, 48118, United States
Clarkston Michigan, 48346, United States
Clarkston Michigan, 48346, United States
Detroit Michigan, 48236, United States
East China Township Michigan, 48054, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Grosse Pointe Woods Michigan, 48236, United States
Grosse Pointe Woods Michigan, 48236, United States
Grosse Pointe Woods Michigan, 48236, United States
Lansing Michigan, 48912, United States
Livonia Michigan, 48154, United States
Livonia Michigan, 48154, United States
Macomb Michigan, 48044, United States
Macomb Michigan, 48044, United States
Marlette Michigan, 48453, United States
Pontiac Michigan, 48341, United States
Pontiac Michigan, 48341, United States
Pontiac Michigan, 48341, United States
Pontiac Michigan, 48341, United States
Rochester Hills Michigan, 48309, United States
Saginaw Michigan, 48601, United States
Saginaw Michigan, 48604, United States
Sterling Heights Michigan, 48312, United States
Tawas City Michigan, 48764, United States
Warren Michigan, 48088, United States
Warren Michigan, 48093, United States
Warren Michigan, 48093, United States
Warren Michigan, 48093, United States
Warren Michigan, 48093, United States
West Branch Michigan, 48661, United States
Ypsilanti Michigan, 48106, United States
Ypsilanti Michigan, 48197, United States
Burnsville Minnesota, 55337, United States
Burnsville Minnesota, 55337, United States
Cambridge Minnesota, 55008, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Maple Grove Minnesota, 55369, United States
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Minneapolis Minnesota, 55454, United States
Monticello Minnesota, 55362, United States
New Ulm Minnesota, 56073, United States
Princeton Minnesota, 55371, United States
Robbinsdale Minnesota, 55422, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Stillwater Minnesota, 55082, United States
Waconia Minnesota, 55387, United States
Willmar Minnesota, 56201, United States
Woodbury Minnesota, 55125, United States
Wyoming Minnesota, 55092, United States
Bonne Terre Missouri, 63628, United States
Cape Girardeau Missouri, 63703, United States
Cape Girardeau Missouri, 63703, United States
Farmington Missouri, 63640, United States
Jefferson City Missouri, 65109, United States
Saint Louis Missouri, 63131, United States
Sainte Genevieve Missouri, 63670, United States
Sullivan Missouri, 63080, United States
Sunset Hills Missouri, 63127, United States
Bronx New York, 10461, United States
Bronx New York, 10461, United States
Bronx New York, 10467, United States
New York New York, 10032, United States
Allentown Pennsylvania, 18103, United States
Bethlehem Pennsylvania, 18017, United States
East Stroudsburg Pennsylvania, 18301, United States
Hazleton Pennsylvania, 18201, United States
Grafton Wisconsin, 53024, United States
Milwaukee Wisconsin, 53215, United States
New Richmond Wisconsin, 54017, United States
West Allis Wisconsin, 53227, United States
Manati , 00674, Puerto Rico
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