Hematopoietic and Lymphatic System NeoplasmNCT02474160
Collection and Storage of Tissue and Blood Samples From Patients With Cancer
An observational study of Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by National Cancer Institute LAO at 140 sites in United States.
Trial summary
This study collects and stores tissue and blood samples from patients with cancer. Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help scientists create new and better models to learn about cancer and to test new cancer drugs. Read more about this study
- Who is it for?
- Ages 2 months and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
- What is being tested?
- Cytology Specimen Collection Procedure
- How many people
- 5,000 participants
- Where
- 140 sitesUnited States
- Study dates
- 19 May 2015to 4 May 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing evaluation and/or treatment for cancer
Who may be able to join
- Patients older than 2 months of age who are being evaluated, treated, or enrolled in a clinical trial for cancer at participating sites
- Patients with a histologically or cytologically confirmed diagnosis of cancer
- Patients without histologically or cytologically confirmed diagnosis of cancer, but for whom approval has been requested and received from the coordinating site study coordinator
- Requests for coordinating site approval should only be made if the patient's existing work-up at the time of the request demonstrates a combination of two or more of the following indicating the greater likelihood of a cancerous process in the assessment of the treating physician:
- Radiographic imaging (computed tomography [CT], magnetic resonance imaging [MRI], etc.)
- Elevated tumor markers
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- Clinical symptoms
- Documented risk factors, known genetic changes (mutation, deletion, fusion, etc.), and/or known familial cancer history or syndrome
- Complete blood count (CBC) w/differential indicative of a probable hematologic malignancy
- If the patient will be undergoing surgical resection at a later time and will be accessible to approach for study participation at that time, resected material following cancer diagnosis confirmation is preferred
- Important: Additional medical, genetic and/or demographic work-up should not be obtained solely for determination of eligibility for protocol 9846 by these criteria. Once available, final histology must be confirmed to the coordinating site detailing the cancer diagnosis for patients enrolled based on the above criteria
- Patients with a newly diagnosed primary and/or metastatic solid tumor or hematologic malignancy for which they have not yet received treatment
- Patients with a solid tumor or hematologic malignancy that is recurrent, newly metastasized, or progressing while on treatment indicated by:
- Radiographic evidence of tumor growth, re-growth, and/or new metastases, OR
- Documentation by the treating physician of clinical disease progression, OR
- CBC w/differential and/or flow cytometry for hematologic malignancies
- Patients currently undergoing treatment (adjuvant, neoadjuvant, etc.)
- Specimen collection should occur as distant in time from the most recent drug administration as possible (e.g., after completion of a treatment cycle and immediately prior to initiation of the next cycle)
- Specimens should not be collected from patients between doses within a single treatment cycle
- Confirmation of viable residual malignancy and/or < 90% tumor necrosis, fibrosis, or hemorrhage must be confirmed to the National Cancer Institute (NCI) coordinating site, as indicated in the final post-operative/post-procedure pathology and/or flow cytometry report
- Patients with ongoing partial response (PR) or stable disease (SD) are eligible
- Confirmation of viable malignancy and/or < 90% tumor necrosis, fibrosis, or hemorrhage must be confirmed to the NCI coordinating site, as indicated in the final post-operative/post-procedure pathology and/or flow cytometry report
- Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or biologic fluid specimens used for research as outlined in this protocol
- For pediatric patients, ability and willingness to assent to participation, using an explanation that is understandable/age appropriate, as well as receiving parental permission. Signature requirements for pediatric patients can be adjusted based on local guidelines
Who cannot join
- Patients with cancer-like syndromes and/or blood disorders such as systemic mastocytosis, Langerhans cell histiocytosis, chronic eosinophilic leukemia/hypereosinophilic syndrome, lymphomatoid granulomatosis, or monoclonal gammopathy of undetermined significance (MGUS)
- Patients with invasive fungal infections
- Patients with active and/or uncontrolled bacterial, fungal, or viral infections or who are still recovering from an infection
- Actively febrile patients with uncertain etiology of febrile episode
- All antibiotics prescribed for the treatment of a bacterial infection should be completed at least 1 week (7 days) prior to collection
- Patients with a hematologic malignancy who are treated with an antibiotic, anti-fungal, and/or anti-viral medication for an active infection who then remain on the treatment for prophylaxis following resolution of the infection as assessed by the treating physician are not excluded
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- No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics
- Patients receiving antibiotics, antifungals, and/or antivirals for prophylaxis are permissible
- Antibiotics being administered topically at a location distant from the planned tissue collection site or eye drops for a localized infection are permissible
- 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 HCV, HBV, or HIV; testing for HBV, HCV, HIV or other infections for eligibility will be performed only if clinically indicated
- Patients with hepatitis A as indicated by anti-hepatitis A virus (HAV) IgM reactivity
- Patients that are anti-HAV IgG reactive only are eligible
- Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR)
Trial locations and contacts
140 sites in 1 country. Contact the study team or a site near you to ask about taking part.
140 sites in 1 country
United States140 sites, 18 recruiting
- Active, not recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
- Active, not recruiting
PCR Oncology
Arroyo Grande, California, 93420
- Active, not recruiting
MultiCare Auburn Medical Center
Auburn, Washington, 98001
- Recruiting
Augusta University Medical Center
Augusta, Georgia, 30912
Site Public Contact, 706-721-2388, ga_cares@augusta.edu
Anand P. Jillella
- Active, not recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
- Active, not recruiting
Virginia Mason Bainbridge Island Medical Center
Bainbridge Island, Washington, 98110
- Active, not recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
- Suspended
Bronson Battle Creek
Battle Creek, Michigan, 49017
- Suspended
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
- Active, not recruiting
OSF Saint Joseph Medical Center
Bloomington, Illinois, 61701
- Suspended
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
- Suspended
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
- Suspended
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628
- Active, not recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Suspended
Cox Cancer Center Branson
Branson, Missouri, 65616
- Suspended
Illinois CancerCare-Canton
Canton, Illinois, 61520
- Suspended
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
- Suspended
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
- Suspended
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
- Suspended
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
- Suspended
Centralia Oncology Clinic
Centralia, Illinois, 62801
- Active, not recruiting
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720
- Suspended
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
- Recruiting
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Site Public Contact, 312-864-5204
Deimante M. Tamkus
- Active, not recruiting
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
- Active, not recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
- Active, not recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
- Active, not recruiting
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801
- Active, not recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
- Active, not recruiting
Duke University Medical Center
Durham, North Carolina, 27710
- Active, not recruiting
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701
- Suspended
Crossroads Cancer Center
Effingham, Illinois, 62401
- Active, not recruiting
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042
- Suspended
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
- Active, not recruiting
Virginia Mason Federal Way Medical Center
Federal Way, Washington, 98002
- Active, not recruiting
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701
- Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Site Public Contact, 800-378-9373
Jay W. Carlson
- Suspended
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
- Suspended
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
- Active, not recruiting
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, 98335
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Suspended
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
- Active, not recruiting
Cancer and Blood Specialists-Henderson
Henderson, Nevada, 89052
- Active, not recruiting
UT MD Anderson Cancer Center
Houston, Texas, 77030
- Active, not recruiting
Cancer Center of Kansas-Independence
Independence, Kansas, 67301
- Suspended
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109
- Recruiting
Freeman Health System
Joplin, Missouri, 64804
Site Public Contact, 417-347-4030, LJCrockett@freemanhealth.com
Jay W. Carlson
- Recruiting
Mercy Hospital Joplin
Joplin, Missouri, 64804
Site Public Contact, 417-556-3074, esmeralda.carrillo@mercy.net
Jay W. Carlson
- Suspended
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
- Suspended
Beacon Kalamazoo
Kalamazoo, Michigan, 49048
- Suspended
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
- Active, not recruiting
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068
- Suspended
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
- Active, not recruiting
Cancer and Blood Specialists-Shadow
Las Vegas, Nevada, 89106
- Active, not recruiting
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, 89109
- Active, not recruiting
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, 89113
- Active, not recruiting
Cancer Therapy and Integrative Medicine
Las Vegas, Nevada, 89121
- Active, not recruiting
Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada, 89128
- Active, not recruiting
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, 89128
- Active, not recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
- Active, not recruiting
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, 89149
- Active, not recruiting
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169
- Active, not recruiting
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89183
- Active, not recruiting
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
- Active, not recruiting
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905
- Active, not recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
- Active, not recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Active, not recruiting
Virginia Mason Lynnwood Medical Center
Lynnwood, Washington, 98036
- Suspended
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
- Active, not recruiting
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, 66502
- Active, not recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
- Recruiting
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Raymond U. Osarogiagbon
- Active, not recruiting
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
- Recruiting
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
Site Public Contact, 618-899-1894, gayla.hall@ssmhealth.com
Jay W. Carlson
- Suspended
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
- Active, not recruiting
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510
- Active, not recruiting
Yale University
New Haven, Connecticut, 06520
- Recruiting
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Site Public Contact, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu
Bret Taback
- Active, not recruiting
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, 19713
- Active, not recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
- Active, not recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
- Active, not recruiting
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
- Active, not recruiting
Cancer Center of Kansas - Newton
Newton, Kansas, 67114
- Suspended
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
- Suspended
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
- Recruiting
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
Site Public Contact, 405-752-3402
Jay W. Carlson
- Suspended
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
- Suspended
Radiation Oncology of Northern Illinois
Ottawa, Illinois, 61350
- Recruiting
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Raymond U. Osarogiagbon
- Active, not recruiting
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357
- Suspended
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
- Suspended
OSF Saint Francis Radiation Oncology at Pekin
Pekin, Illinois, 61554
- Suspended
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
- Suspended
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615
- Suspended
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
- Suspended
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
- Suspended
Illinois CancerCare-Peru
Peru, Illinois, 61354
- Suspended
Valley Radiation Oncology
Peru, Illinois, 61354
- Active, not recruiting
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124
- Suspended
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
- Active, not recruiting
MultiCare Good Samaritan Hospital
Puyallup, Washington, 98372
- Suspended
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
- Active, not recruiting
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
- Active, not recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
- Suspended
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
- Recruiting
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, 65401
Site Public Contact, 573-458-7504, research@phelpshealth.org
Jay W. Carlson
- Suspended
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
- Suspended
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
- Recruiting
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
Site Public Contact, 816-271-7937, Trisha.England2@mymlc.com
Jay W. Carlson
- Suspended
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
- Active, not recruiting
Cancer Center of Kansas - Salina
Salina, Kansas, 67401
- Active, not recruiting
Virginia Mason Medical Center
Seattle, Washington, 98101
- Active, not recruiting
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62702
- Suspended
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
- Suspended
Springfield Clinic
Springfield, Illinois, 62702
- Suspended
Springfield Memorial Hospital
Springfield, Illinois, 62781
- Recruiting
Mercy Hospital Springfield
Springfield, Missouri, 65804
Site Public Contact, 417-269-4520
Jay W. Carlson
- Recruiting
CoxHealth South Hospital
Springfield, Missouri, 65807
Site Public Contact, 417-269-4520
Jay W. Carlson
- Suspended
Mercy Infusion Center - Chippewa
St Louis, Missouri, 63109
- Active, not recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
- Recruiting
Mercy Hospital South
St Louis, Missouri, 63128
Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net
Jay W. Carlson
- Active, not recruiting
Missouri Baptist Medical Center
St Louis, Missouri, 63131
- Recruiting
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Site Public Contact, 314-251-7066
Jay W. Carlson
- Active, not recruiting
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
- Suspended
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
- Recruiting
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405
Site Public Contact, 253-403-3229, research@multicare.org
John A. Keech
- Active, not recruiting
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
- Active, not recruiting
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461
- Active, not recruiting
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
- Suspended
Munson Medical Center
Traverse City, Michigan, 49684
- Active, not recruiting
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401
- Active, not recruiting
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152
- Active, not recruiting
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
- Active, not recruiting
Associates In Womens Health
Wichita, Kansas, 67208
- Active, not recruiting
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208
- Active, not recruiting
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214
- Active, not recruiting
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214
- Active, not recruiting
Wesley Medical Center
Wichita, Kansas, 67214
- Active, not recruiting
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801
- Active, not recruiting
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156
About this study
Official title: Patient-Derived Models Tissue Procurement Protocol for the National Cancer Institute (NCI)
This study collects and stores tissue and blood samples from patients with cancer. Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help scientists create new and better models to learn about cancer and to test new cancer drugs.
Read the detailed description
PRIMARY OBJECTIVE:
- To procure biologic tissues and materials to generate preclinical models of cancer.
OUTLINE: This is an observational study.
Tumor tissue and blood samples are procured during procedures that are required for the patients' clinical management and will be stored via xenograft (transplant to another species) models or in vitro cell culture for future analysis.
- Conditions
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm
- Being tested
- Cytology Specimen Collection Procedure
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Procurement of tissue and blood samples
| Study group | Role | What they receive |
|---|---|---|
| Observational (tissue and blood procurement) | Tumor tissue and blood samples are procured during procedures that are required for the patients' clinical management and stored via xenograft (transplant to another species) models or in vitro cell culture for future analysis. Receives: Other: Cytology Specimen Collection Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procurement of tissue and blood specimens for research purposes
Tissues and venous blood will be stored, implanted immediately to generate patient-derived xenografts (which require fresh, viable cells), or placed immediately into in vitro cell culture to generate patient-derived cell lines (which require fresh, viable cells).
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study start19 May 2015
- Primary completion4 May 2028 (estimated)
- Study completion4 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute LAO
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James H Doroshow, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474160
- Sponsor's protocol ID
- NCI-2015-00863
- Other IDs
- NCI-2015-00863, P9846, P9846_R02PAPPHOLD01, 9846, 9846, UM1CA186689, UM1CA186691, UM1CA186704
- Status last verified
- Oct 2026
- First submitted
- 15 Jun 2015
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No