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NCT03707574 Clinical Trial

Genetic Analysis of Blood and Tissue Samples From Patients With Advanced Cancer, Moonshot Study

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:
NCORP Tissue Procurement Protocol: An NCI Cancer Moonshot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03707574
Other study ID # NCI-2018-01375
Secondary ID NCI-2018-0137510
Status Active, not recruiting
Phase
First received
Last updated
Start date April 9, 2019
Est. completion date May 1, 2024

Study information
Verified date December 2023
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date May 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Adenocarcinoma
  • Advanced Malignant Neoplasm
  • Advanced Melanoma
  • Advanced Renal Cell Carcinoma
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Breast Neoplasms
  • Carcinoma, Ovarian Epithelial
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Colorectal Neoplasms
  • Esophageal Neoplasms
  • Lung Neoplasms
  • Ovarian Neoplasms
  • Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Prognostic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8
  • Prognostic Stage IV Breast Cancer AJCC v8
  • Prostatic Neoplasms
  • Stage III Colorectal Cancer AJCC v8
  • Stage III Lung Cancer AJCC v8
  • Stage III Ovarian Cancer AJCC v8
  • Stage III Prostate Cancer AJCC v8
  • Stage IIIA Colorectal Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIA Ovarian Cancer AJCC v8
  • Stage IIIA Prostate Cancer AJCC v8
  • Stage IIIA1 Ovarian Cancer AJCC v8
  • Stage IIIA2 Ovarian Cancer AJCC v8
  • Stage IIIB Colorectal Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIB Ovarian Cancer AJCC v8
  • Stage IIIB Prostate Cancer AJCC v8
  • Stage IIIC Colorectal Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IIIC Ovarian Cancer AJCC v8
  • Stage IIIC Prostate Cancer AJCC v8
  • Stage IV Colorectal Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IV Prostate Cancer AJCC v8
  • Stage IVA Colorectal Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVA Ovarian Cancer AJCC v8
  • Stage IVA Prostate Cancer AJCC v8
  • Stage IVB Colorectal Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8
  • Stage IVB Ovarian Cancer AJCC v8
  • Stage IVB Prostate Cancer AJCC v8
  • Stage IVC Colorectal Cancer AJCC v8

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood and tissue

Locations
Country Name City State
Puerto Rico Doctors Cancer Center Manati
United States Hawaii Cancer Care - Westridge 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States Queen's Cancer Center - Pearlridge 'Aiea Hawaii
United States The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States Saint Joseph Mercy Brighton Brighton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States Fairview Ridges Hospital Burnsville Minnesota
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States Cambridge Medical Center Cambridge Minnesota
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Joseph Mercy Canton Canton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Caro Cancer Center Caro Michigan
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Physicians' Clinic of Iowa PC Cedar Rapids Iowa
United States Centralia Oncology Clinic Centralia Illinois
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Mercy Hospital Coon Rapids Minnesota
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Illinois CancerCare-Dixon Dixon Illinois
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Pocono Medical Center East Stroudsburg Pennsylvania
United States Fairview Southdale Hospital Edina Minnesota
United States Crossroads Cancer Center Effingham Illinois
United States Illinois CancerCare-Eureka Eureka Illinois
United States Parkland Health Center - Farmington Farmington Missouri
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Holy Cross Hospital Fort Lauderdale Florida
United States Unity Hospital Fridley Minnesota
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan
United States Lehigh Valley Hospital-Hazleton Hazleton Pennsylvania
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Island Urology Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Kuakini Medical Center Honolulu Hawaii
United States Queen's Cancer Cenrer - POB I Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Capital Region Southwest Campus Jefferson City Missouri
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States University of Michigan Health - Sparrow Lansing Lansing Michigan
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Hope Cancer Clinic Livonia Michigan
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Michigan Breast Specialists-Macomb Township Macomb Michigan
United States Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States East Jefferson General Hospital Metairie Louisiana
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Monticello Cancer Center Monticello Minnesota
United States Louisiana State University Health Science Center New Orleans Louisiana
United States University Medical Center New Orleans New Orleans Louisiana
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States 21st Century Oncology-Pontiac Pontiac Michigan
United States Hope Cancer Center Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Fairview Northland Medical Center Princeton Minnesota
United States Illinois CancerCare-Princeton Princeton Illinois
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Memorial Medical Center Springfield Illinois
United States Mercy Medical Center Springfield Massachusetts
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Lakeview Hospital Stillwater Minnesota
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States BJC Outpatient Center at Sunset Hills Sunset Hills Missouri
United States Southwest Illinois Health Services LLP Swansea Illinois
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States Ridgeview Medical Center Waconia Minnesota
United States Advanced Breast Care Center PLLC Warren Michigan
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Macomb Hematology Oncology PC Warren Michigan
United States Michigan Breast Specialists-Warren Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States Methodist West Hospital West Des Moines Iowa
United States Rice Memorial Hospital Willmar Minnesota
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Fairview Lakes Medical Center Wyoming Minnesota
United States Huron Gastroenterology PC Ypsilanti Michigan
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Obtaining tumor tissue and blood specimens Will obtain tumor tissue and blood specimens for biobanking and to store tissues, blood, and nucleic acids for future research, including the study of matched pre and post-treatment tumor biopsies to elucidate mechanisms of resistance. Cases will be grouped according to histology and/or treatment. Up to 2 years
Secondary Tumor tissues storage in the Biopathology Center (BPC) at Nationwide Children's Hospital (NCH) (Biorepository) Up to 2 years
Secondary Genomic analysis Will perform genomic studies, including a pan-cancer gene panel, and contribute molecular data to the genomic data commons. Up to 2 years
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