National Cancer Institute "Cancer Moonshot Biobank"

Cancer Moonshot Biobank Research Protocol

Sponsors

Lead Sponsor: National Cancer Institute (NCI)

Source National Cancer Institute (NCI)
Brief Summary

This trial collects multiple tissue and blood samples, along with medical information, from cancer patients. The "Cancer Moonshot Biobank" is a longitudinal study. This means it collects and stores samples and information over time, throughout the course of a patient's cancer treatment. By looking at samples and information collected from the same people over time, researchers hope to better understand how cancer changes over time and over the course of medical treatments.

Detailed Description

PRIMARY OBJECTIVE: I. To support current and future investigations into drug resistance and sensitivity and other National Cancer Institute (NCI)-sponsored cancer research initiatives through the procurement and distribution of multiple longitudinal biospecimens and associated data from a diverse group of cancer patients who are undergoing standard of care treatment at NCI Community Oncology Research Program (NCORP) sites. SECONDARY OBJECTIVES: I. To provide a service of value to study participants and their medical providers through the performance of a molecular profiling assay on tumor samples in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory and reporting of results to physicians and patients that they may opt to use in clinical management, including analysis of data for acquired resistance mechanisms. II. To enable the development of patient-derived models such as cell lines and xenografts for cancer researchers through the provision of biospecimens from 20% of study participants to the NCI's Patient Derived Models Repository (PDMR), a national resource available to investigators. III. To develop and implement robust approaches in patient and provider engagement to improve understanding of biobanking and its relationship to cancer research and increase representation of minority and underserved study participants in cancer research. IV. To develop increased capabilities in United States (U.S.) community hospitals and clinics for contribution to cancer research through biobanking activities. V. To enable secondary research generated from the project through deposition of data in public repositories such as Cancer Research Data Commons (CRDC), The Cancer Imaging Archive (TCIA) and database of Genotypes and Phenotypes (dbGAP), including clinical, radiology and pathology data with an emphasis on treatment response and outcome data. VI. To provide residual biospecimens and associated data from the project to the cancer research community. OUTLINE: Patients undergo collection of tissue and blood samples prior to initiation of treatment, during treatment, and at disease progression. Patients with hematological malignancies also undergo collection of bone marrow and cerebral spinal fluid at the same time points. Archival blood and tissue, as well as bone marrow of patients with hematological malignancies, is also collected, if available. Patient medical records are reviewed, and data is collected for at least 10 years.

Overall Status Recruiting
Start Date 2020-09-17
Completion Date 2025-09-16
Primary Completion Date 2025-09-16
Study Type Observational
Primary Outcome
Measure Time Frame
Procure, store and distribute longitudinal biospecimens and associated clinical data Up to 10 years
Percentage of enrolled patients by cancer type and treatment regimen overall Until completion of biospecimen collection, up to 3 years
Percentage of minority and underserved study participants accrued Until completion of biospecimen collection, up to 3 years
Secondary Outcome
Measure Time Frame
Pan-cancer gene panel tumor next generation sequencing test Until completion of biospecimen collection, up to 3 years
Cancer Research Data Commons, The Cancer Imaging Archive and database of Genotypes and Phenotypes data contribution Until completion of biospecimen collection, up to 3 years
Percentage of minority and underserved study participants accrued Until completion of biospecimen collection, up to 3 years
Percentage of enrolled patients for whom molecular profiling is attempted Until completion of biospecimen collection, up to 3 years
Percentage of enrolled patients for whom molecular profiling results are generated Until completion of biospecimen collection, up to 3 years
Percentage of enrolled patients for whom samples are obtained at each longitudinal timepoint Until completion of biospecimen collection, up to 3 years
Percentage of collected biospecimens that are delivered to the Patient Derived Models Repository Until completion of biospecimen collection, up to 3 years
Enrollment 1000
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Biospecimen Collection

Description: Undergo collection of blood, tissue, bone marrow, and cerebral spinal fluid samples

Arm Group Label: Ancillary-correlative (biospecimen collection, chart review)

Intervention Type: Other

Intervention Name: Medical Chart Review

Description: Medical charts are reviewed and data is collected

Arm Group Label: Ancillary-correlative (biospecimen collection, chart review)

Other Name: Chart Review

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: - Patient diagnosed with Stage IV colorectal cancer, Stage III/IV non-small cell or small cell lung cancer, metastatic castration-resistant prostate cancer, stage IV gastroesophageal cancer, stage III/IV melanoma, or treatment refractory multiple myeloma, is undergoing first or subsequent lines of standard of care therapy per National Comprehensive Cancer Network (NCCN) guidelines and has consented to provide longitudinal biospecimens - Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 may be enrolled retrospectively (i.e. at time of progression) if archival material is submitted that contains the cancer type for which the participant is enrolled and that was collected up to 5 years prior to initiation of a therapy, assuming that no more than 1 line of intervening standard of care systemic therapy was administered from the date of archival material collection to the date of initiation of therapy. Patients with a PS of 2 may be enrolled only at the discretion of the treating physician and radiologist - Age 13 or older, any sex and any gender may be enrolled, but participants under the age of majority will only contribute biospecimens from procedures that are scheduled due to medical necessity and not for the sole purpose of collecting samples for this study - 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 biospecimens. However, research biospecimens 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 - The following tumors may be collected only when patients will be undergoing a procedure due to medical necessity during which the tissue may be collected and not for the sole purpose of the clinical study: - 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 - Study participants with lung cancer (LCA), colorectal cancer (CRC), prostate cancer (PCA), gastroesophageal cancer (GEC), melanoma (MEL), and multiple myeloma (MML) may contribute samples for Patient Derived Models (PDM) development if they meet specific Patient Derived Models Repository (PDMR) eligibility criteria - To ensure that individuals who experience diminished decision making capacity during the course of their cancer treatment are eligible, consent may be provided by a legally authorized representative (LAR) in accordance with 45 Code of Federal Regulations (CFR) 46.102(i). This protocol is minimal risk - NCI PDMR INCLUSION CRITERIA: Baseline and progression timepoints - NCI PDMR INCLUSION CRITERIA: CRC must be mismatch repair deficient and/or microsatellite instability-high Exclusion Criteria: - Patients who are currently or have previously enrolled in an oncology interventional clinical trial - Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy - 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 - Patients with CRC, LCA, PCA, GEC and MEL who are being evaluated at NCORP sites that are currently participating in the NCORP Tissue Procurement Protocol #10231 - NCI PDMR EXCLUSION CRITERIA: Patients with complete response - NCI PDMR EXCLUSION CRITERIA: Patients with invasive fungal infections - NCI PDMR EXCLUSION CRITERIA: Patients with active and/or uncontrolled infections or who are still recovering from an infection - Actively febrile patients with uncertain etiology of febrile episode - All antibiotics for non-prophylactic treatment of infection should be completed at least 1 week (7 days) prior to collection - No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics - NCI PDMR EXCLUSION CRITERIA: Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA]) or known history of HBV/HCV without documented resolution

Gender:

All

Minimum Age:

13 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Helen M Moore Principal Investigator National Cancer Institute (NCI)
Location
Facility: Status: Contact: Investigator:
Kingman Regional Medical Center | Kingman, Arizona, 86401, United States Recruiting Site Public Contact 702-384-0013 [email protected] John A. Ellerton Principal Investigator
Mercy Hospital Fort Smith | Fort Smith, Arkansas, 72903, United States Recruiting Site Public Contact 800-378-9373 Jay W. Carlson Principal Investigator
PCR Oncology | Arroyo Grande, California, 93420, United States Recruiting Site Public Contact 702-384-0013 [email protected] John A. Ellerton Principal Investigator
Northside Hospital | Atlanta, Georgia, 30342, United States Recruiting Site Public Contact 404-303-3355 [email protected] Stephen J. Wells Principal Investigator
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah, Georgia, 31405, United States Recruiting Site Public Contact 912-819-5704 [email protected] Howard A. Zaren Principal Investigator
John H Stroger Jr Hospital of Cook County | Chicago, Illinois, 60612, United States Recruiting Site Public Contact 312-864-5204 Thomas E. Lad Principal Investigator
Carle on Vermilion | Danville, Illinois, 61832, United States Recruiting Site Public Contact 800-446-5532 [email protected] Kendrith M. Rowland Principal Investigator
Cancer Care Specialists of Illinois - Decatur | Decatur, Illinois, 62526, United States Recruiting Site Public Contact 217-876-4762 [email protected] Bryan A. Faller Principal Investigator
Decatur Memorial Hospital | Decatur, Illinois, 62526, United States Recruiting Site Public Contact 217-876-4762 [email protected] Bryan A. Faller Principal Investigator
Carle Physician Group-Mattoon/Charleston | Mattoon, Illinois, 61938, United States Recruiting Site Public Contact 800-446-5532 [email protected] Kendrith M. Rowland Principal Investigator
Good Samaritan Regional Health Center | Mount Vernon, Illinois, 62864, United States Recruiting Site Public Contact 618-242-4600 Jay W. Carlson Principal Investigator
Carle Cancer Center | Urbana, Illinois, 61801, United States Recruiting Site Public Contact 800-446-5532 [email protected] Kendrith M. Rowland Principal Investigator
McFarland Clinic PC - Ames | Ames, Iowa, 50010, United States Recruiting Site Public Contact 515-239-4734 [email protected] Debra M. Prow Principal Investigator
Physicians' Clinic of Iowa PC | Cedar Rapids, Iowa, 52402, United States Recruiting Site Public Contact 319-297-2900 William P. Fusselman Principal Investigator
Oncology Associates at Mercy Medical Center | Cedar Rapids, Iowa, 52403, United States Recruiting Site Public Contact 319-363-2690 Deborah W. Wilbur Principal Investigator
Blank Children's Hospital | Des Moines, Iowa, 50309, United States Recruiting Site Public Contact 515-241-8912 [email protected] Samantha L. Mallory Principal Investigator
Iowa Methodist Medical Center | Des Moines, Iowa, 50309, United States Recruiting Site Public Contact 515-241-6727 Joshua Lukenbill Principal Investigator
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa, 50309, United States Recruiting Site Public Contact 515-282-2921 Joshua Lukenbill Principal Investigator
Harold Alfond Center for Cancer Care | Augusta, Maine, 04330, United States Recruiting Site Public Contact 207-626-4855 Anne C. Breggia Principal Investigator
Waldo County General Hospital | Belfast, Maine, 04915, United States Recruiting Site Public Contact 207-338-2500 Anne C. Breggia Principal Investigator
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford | Biddeford, Maine, 04005, United States Recruiting Site Public Contact [email protected] Anne C. Breggia Principal Investigator
Franklin Memorial Hospital | Farmington, Maine, 04938, United States Recruiting Site Public Contact 207-396-8670 [email protected] Anne C. Breggia Principal Investigator
Stephens Memorial Hospital | Norway, Maine, 04268, United States Recruiting Site Public Contact 207-396-8670 [email protected] Anne C. Breggia Principal Investigator
Maine Medical Center-Bramhall Campus | Portland, Maine, 04102, United States Recruiting Site Public Contact 207-885-7565 Anne C. Breggia Principal Investigator
Maine Medical Partners Surgical Care | Portland, Maine, 04102, United States Recruiting Site Public Contact 207-396-8670 [email protected] Anne C. Breggia Principal Investigator
MMP Surgical Care Casco Bay | Portland, Maine, 04102, United States Recruiting Site Public Contact 207-396-8670 [email protected] Anne C. Breggia Principal Investigator
Penobscot Bay Medical Center | Rockport, Maine, 04856, United States Recruiting Site Public Contact 207-396-8670 [email protected] Anne C. Breggia Principal Investigator
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford | Sanford, Maine, 04073, United States Recruiting Site Public Contact [email protected] Anne C. Breggia Principal Investigator
Maine Children's Cancer Program | Scarborough, Maine, 04074, United States Recruiting Site Public Contact 207-396-7581 [email protected] Anne C. Breggia Principal Investigator
Maine Medical Partners Neurology | Scarborough, Maine, 04074, United States Recruiting Site Public Contact 207-396-8670 [email protected] Anne C. Breggia Principal Investigator
Maine Medical Partners - South Portland | South Portland, Maine, 04106, United States Recruiting Site Public Contact 207-396-8670 [email protected] Anne C. Breggia Principal Investigator
Maine Medical Partners Urology | South Portland, Maine, 04106, United States Recruiting Site Public Contact 207-396-8670 [email protected] Anne C. Breggia Principal Investigator
Saint Joseph Mercy Hospital | Ann Arbor, Michigan, 48106, United States Recruiting Site Public Contact 734-712-3671 [email protected] Philip J. Stella Principal Investigator
Saint Joseph Mercy Brighton | Brighton, Michigan, 48114, United States Recruiting Site Public Contact 734-712-3671 [email protected] Philip J. Stella Principal Investigator
Saint Joseph Mercy Canton | Canton, Michigan, 48188, United States Recruiting Site Public Contact 734-712-3671 [email protected] Philip J. Stella Principal Investigator
Saint Joseph Mercy Chelsea | Chelsea, Michigan, 48118, United States Recruiting Site Public Contact 734-712-3671 [email protected] Philip J. Stella Principal Investigator
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan, 49503, United States Recruiting Site Public Contact 616-391-1230 [email protected] Kathleen J. Yost Principal Investigator
Saint Louis Cancer and Breast Institute-Ballwin | Ballwin, Missouri, 63011, United States Recruiting Site Public Contact 314-251-7058 Jay W. Carlson Principal Investigator
Freeman Health System | Joplin, Missouri, 64804, United States Recruiting Site Public Contact 417-347-4030 [email protected] Jay W. Carlson Principal Investigator
Mercy Hospital Joplin | Joplin, Missouri, 64804, United States Recruiting Site Public Contact 417-556-3074 [email protected] Jay W. Carlson Principal Investigator
Delbert Day Cancer Institute at PCRMC | Rolla, Missouri, 65401, United States Recruiting Site Public Contact 573-458-7504 [email protected] Jay W. Carlson Principal Investigator
Mercy Clinic-Rolla-Cancer and Hematology | Rolla, Missouri, 65401, United States Recruiting Site Public Contact 573-458-6379 Jay W. Carlson Principal Investigator
Heartland Regional Medical Center | Saint Joseph, Missouri, 64506, United States Recruiting Site Public Contact 816-271-7937 [email protected] Jay W. Carlson Principal Investigator
Saint Louis Cancer and Breast Institute-South City | Saint Louis, Missouri, 63109, United States Recruiting Site Public Contact 314-353-1870 Jay W. Carlson Principal Investigator
Mercy Hospital South | Saint Louis, Missouri, 63128, United States Recruiting Site Public Contact [email protected] Jay W. Carlson Principal Investigator
Missouri Baptist Medical Center | Saint Louis, Missouri, 63131, United States Recruiting Site Public Contact 314-996-5569 Bryan A. Faller Principal Investigator
Mercy Hospital Saint Louis | Saint Louis, Missouri, 63141, United States Recruiting Site Public Contact 314-251-7066 Jay W. Carlson Principal Investigator
Mercy Hospital Springfield | Springfield, Missouri, 65804, United States Recruiting Site Public Contact 417-269-4520 Jay W. Carlson Principal Investigator
CoxHealth South Hospital | Springfield, Missouri, 65807, United States Recruiting Site Public Contact 417-269-4520 Jay W. Carlson Principal Investigator
Mercy Hospital Washington | Washington, Missouri, 63090, United States Recruiting Site Public Contact 636-390-1600 Jay W. Carlson Principal Investigator
CHI Health Saint Francis | Grand Island, Nebraska, 68803, United States Recruiting Site Public Contact 855-313-2409 [email protected] Ryan C. Ramaekers Principal Investigator
OptumCare Cancer Care at Seven Hills | Henderson, Nevada, 89052, United States Recruiting Site Public Contact 702-384-0013 [email protected] John A. Ellerton Principal Investigator
OptumCare Cancer Care at Charleston | Las Vegas, Nevada, 89102, United States Recruiting Site Public Contact 702-384-0013 [email protected] John A. Ellerton Principal Investigator
Hope Cancer Care of Nevada | Las Vegas, Nevada, 89103, United States Recruiting Site Public Contact 702-384-0013 [email protected] John A. Ellerton Principal Investigator
Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas, Nevada, 89135, United States Recruiting Site Public Contact 702-384-0013 [email protected] John A. Ellerton Principal Investigator
Comprehensive Cancer Centers of Nevada - Town Center | Las Vegas, Nevada, 89144, United States Recruiting Site Public Contact 702-384-0013 [email protected] John A. Ellerton Principal Investigator
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada, 89148, United States Recruiting Site Public Contact 702-384-0013 [email protected] John A. Ellerton Principal Investigator
OptumCare Cancer Care at Fort Apache | Las Vegas, Nevada, 89148, United States Recruiting Site Public Contact 702-384-0013 [email protected] John A. Ellerton Principal Investigator
Comprehensive Cancer Centers of Nevada - Central Valley | Las Vegas, Nevada, 89169, United States Recruiting Site Public Contact 702-384-0013 [email protected] John A. Ellerton Principal Investigator
Morristown Medical Center | Morristown, New Jersey, 07960, United States Recruiting Site Public Contact 973-971-5900 Eric D. Whitman Principal Investigator
Newton Medical Center | Newton, New Jersey, 07860, United States Suspended
Chilton Medical Center | Pompton, New Jersey, 07444, United States Suspended
Overlook Hospital | Summit, New Jersey, 07902, United States Recruiting Site Public Contact 908-522-2043 Eric D. Whitman Principal Investigator
Montefiore Medical Center-Einstein Campus | Bronx, New York, 10461, United States Recruiting Site Public Contact 718-379-6866 [email protected] Balazs Halmos Principal Investigator
Montefiore Medical Center-Weiler Hospital | Bronx, New York, 10461, United States Recruiting Site Public Contact 718-379-6866 [email protected] Balazs Halmos Principal Investigator
Montefiore Medical Center - Moses Campus | Bronx, New York, 10467, United States Recruiting Site Public Contact 718-379-6866 [email protected] Balazs Halmos Principal Investigator
Mercy Hospital Oklahoma City | Oklahoma City, Oklahoma, 73120, United States Recruiting Site Public Contact 405-752-3402 Jay W. Carlson Principal Investigator
Prisma Health Richland Hospital | Columbia, South Carolina, 29203, United States Recruiting Site Public Contact 864-241-6251 Ki Y. Chung Principal Investigator
Prisma Health Baptist Hospital | Columbia, South Carolina, 29220, United States Recruiting Site Public Contact 864-241-6251 Ki Y. Chung Principal Investigator
Prisma Health Greenville Memorial Hospital | Greenville, South Carolina, 29605, United States Recruiting Site Public Contact 864-241-6251 Ki Y. Chung Principal Investigator
Gibbs Cancer Center-Pelham | Greer, South Carolina, 29651, United States Recruiting Site Public Contact 864-560-6104 [email protected] Michael Humeniuk Principal Investigator
Spartanburg Medical Center | Spartanburg, South Carolina, 29303, United States Recruiting Site Public Contact 864-560-6104 [email protected] Michael Humeniuk Principal Investigator
Centra Lynchburg Hematology-Oncology Clinic Inc | Lynchburg, Virginia, 24501, United States Recruiting Site Public Contact 434-200-5925 [email protected] Andrew Poklepovic Principal Investigator
VCU Massey Cancer Center at Stony Point | Richmond, Virginia, 23235, United States Recruiting Site Public Contact [email protected] Andrew Poklepovic Principal Investigator
Virginia Commonwealth University/Massey Cancer Center | Richmond, Virginia, 23298, United States Recruiting Site Public Contact [email protected] Andrew Poklepovic Principal Investigator
Valley Medical Center | Renton, Washington, 98055, United States Recruiting Site Public Contact 425-228-3440 [email protected] John A. Ellerton Principal Investigator
Marshfield Medical Center-EC Cancer Center | Eau Claire, Wisconsin, 54701, United States Recruiting Site Public Contact 800-782-8581 [email protected] Adedayo A. Onitilo Principal Investigator
Marshfield Medical Center-Marshfield | Marshfield, Wisconsin, 54449, United States Recruiting Site Public Contact 800-782-8581 [email protected] Adedayo A. Onitilo Principal Investigator
Aurora Saint Luke's Medical Center | Milwaukee, Wisconsin, 53215, United States Recruiting Site Public Contact 414-302-2304 [email protected] Michael A. Thompson Principal Investigator
Marshfield Clinic-Minocqua Center | Minocqua, Wisconsin, 54548, United States Recruiting Site Public Contact 800-782-8581 [email protected] Adedayo A. Onitilo Principal Investigator
Marshfield Medical Center-Rice Lake | Rice Lake, Wisconsin, 54868, United States Recruiting Site Public Contact 800-782-8581 [email protected] Adedayo A. Onitilo Principal Investigator
Marshfield Clinic Stevens Point Center | Stevens Point, Wisconsin, 54482, United States Recruiting Site Public Contact 800-782-8581 [email protected] Adedayo A. Onitilo Principal Investigator
Marshfield Medical Center - Weston | Weston, Wisconsin, 54476, United States Recruiting Site Public Contact 800-782-8581 [email protected] Adedayo A. Onitilo Principal Investigator
Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin, 54494, United States Recruiting Site Public Contact 800-782-8581 [email protected] Adedayo A. Onitilo Principal Investigator
San Juan Community Oncology Group | San Juan, 00917, Puerto Rico Recruiting Site Public Contact 787-274-3387 Luis Baez-Diaz Principal Investigator
Centro Comprensivo de Cancer de UPR | San Juan, 00927, Puerto Rico Recruiting Site Public Contact 888-823-5923 [email protected] Luis Baez-Diaz Principal Investigator
San Juan City Hospital | San Juan, 00936, Puerto Rico Recruiting Site Public Contact 787-763-1296 Luis Baez-Diaz Principal Investigator
Location Countries

Puerto Rico

United States

Verification Date

2021-07-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Ancillary-correlative (biospecimen collection, chart review)

Description: Patients undergo collection of tissue and blood samples prior to initiation of treatment, during treatment, and at disease progression. Patients with hematological malignancies also undergo collection of bone marrow and cerebral spinal fluid at the same time points. Archival blood and tissue, as well as bone marrow of patients with hematological malignancies, is also collected, if available. Patient medical records are reviewed, and data is collected for at least 10 years.

Patient Data Yes
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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