jueves, 4 de agosto de 2016

NCT02775383 Clinical Trial - National Cancer Institute

NCT02775383 Clinical Trial - National Cancer Institute

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National Cancer Institute

Tissue Collection and Natural History Study of Patients with Myelodysplastic Syndrome or Myeloproliferative Neoplasms





Basic Trial Information

PhaseTypeStatusAgeTrial IDs
No phase specifiedNatural history/Epidemiology, Tissue collection/RepositoryActive18 and overNHLBI-MDS
NCI-2016-00281, NCT02775383

Trial Description

Summary

This research trial collects tissue samples from and studies the history of patients with myelodysplastic syndrome (MDS) or myeloproliferative neoplasms (MPN). Collecting and storing patients' bone marrow, blood, eyebrow hairs, buccal swab, skin, or other tissues to be studied in the laboratory in the future may help doctors learn more about MDS and blood disorders that may lead to MDS. Collecting information about patients and the treatments they receive may allow doctors to better understand how MDS changes over time and this knowledge may lead to better ways to prevent, detect, and treat MDS in the future.

Further Study Information

PRIMARY OBJECTIVES:
I. To develop a high-quality clinical database containing clinical history, including environmental exposure history, presenting signs and symptoms, diagnostic testing results, co-existing diseases, therapies and response to therapies, disease progression, quality of life and survival.
II. To develop a high-quality biorepository linked to the clinical data that will facilitate diverse studies, including genetic, epigenetic, immunologic, proteomic, and cell-functional and cell-phenotypic studies through the development of: central communication with the biorepository to ensure timely and accurate collections and biospecimen data appended to the clinical database; defined standard operating procedures for the collection, processing, storage and distribution, with special emphasis on processing protocols fit-for-purpose to sample requirements for downstream testing; and quality management procedures to ensure minimal numbers of errors in the management of the biospecimens.
III. To facilitate broad use of these linked data and specimens to support studies focused on: improving diagnostic accuracy, risk-stratification and prognostication, and medical decision-making in MDS; understanding quality of life and its relationship to changing disease and treatment status; understanding the pathogenesis of MDS and diverse MDS subtypes, including genetic, epigenetic, immunologic mechanisms; optimizing treatment strategies for specific subtypes of MDS; identifying novel biomarkers for MDS outcomes; and identifying novel targets for therapeutic interventions in MDS.
SECONDARY OBJECTIVES:
I. Detecting improved prognostic factors in low risk MDS. (Potential Studies)
II. Detecting markers of improved response to hypomethylating therapy. (Potential Studies)
III. Quality of life (QOL) and anemia therapy. (Potential Studies)
IV. Genetic factors in patients with complex karyotype. (Potential Studies)
V. Prognostic significance of splicing factor 3b subunit 1 (SF3B1) in MDS patients with refractory anemia with ring sideroblasts (RARS). (Potential Studies)
OUTLINE:
Patients undergo blood, bone marrow, eyebrow hairs, buccal swab and optional skin biopsy. Patients' medical records, baseline laboratory tests, quality of life, and diagnostic information including pathology reports and treatment history are also reviewed.
After the baseline visit, patients are followed up every 6 months. Follow up visits include disease evaluation, physical examination and collection of peripheral blood sample. Bone marrow biopsy and aspiration is performed when clinically necessary. Patients also complete the MDS-specific Qualify of Life in Myelodysplasia Scale (QUALMS), Functional Assessment of Cancer Therapy-General (FACT-G) (version 4), the Patient Reported Outcome Measurement Information System (PROMIS) Short Form version 1.0-Fatigue 7a, and the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L).

Eligibility Criteria

Inclusion Criteria:
Suspected (e.g., persistent unexplained cytopenia, circulating peripheral blasts etc.) MDS or MDS/MPN overlap disorders and undergoing diagnostic work-up with planned bone marrow assessments OR
Diagnosed with de novo or therapy-related MDS within 6-months of enrollment per the World Health Organization (WHO) criteria and undergoing clinical evaluation and planned bone marrow assessments to confirm MDS or to evaluate disease status
Bone marrow aspirate expected to be performed within 1 week of registration, and in all cases must be performed no later than 4 weeks after enrollment
No prior treatment for MDS at entry and through the time of the entry bone marrow aspirate
No treatment with hematopoietic growth factors in prior 6 months
B12 level, serum folate, ferritin, and thyroid-stimulating hormone (TSH) tests performed in prior 6 months
No diagnosis of a solid tumor or hematologic malignancy within two years prior to enrollment except for in situ cancer of the skin (basal or squamous cell), cervix, bladder, breast, or prostate
No treatment with radiation therapy in the two years prior to registration
No non-hormonal treatment for malignancy within the two years prior to registration
No established hereditary bone marrow failure syndrome
No known primary diagnosis of aplastic anemia, classical paroxysmal nocturnal hemoglobinuria, amegakaryocytic thrombocytopenic purpura, or large granular lymphocyte leukemia
Not enrolled in the Connect® MDS/Acute Myeloid Leukemia (AML) Disease Registry
In participants with suspected MDS and prior to registration with subsequent bone marrow evaluation, alternative causes for the cytopenias should be considered (e.g., internal bleeding, autoimmune cytopenias, thyroid disorders, other causes of anemia etc.); in select individuals, the following tests could be performed to assist in the diagnostic work-up; these evaluations are not required by the protocol; however, abnormal results in advance of enrollment may reduce the number of non-MDS cases
Copper, serum level
Iron studies (iron, total iron-binding capacity [TIBC] test, percent saturation)
Direct antiglobulin test
Antinuclear antibody (ANA) test
Based on centralized pathology review, participants will be classified into cases (MDS, MDS/MPN overlap disorders, or idiopathic cytopenia of undetermined significance [ICUS]) and others; in addition to baseline biological samples, longitudinal samples and data will be collected for approximately 2000 cases of MDS or MDS/MPN overlap disorders and 500 cases of ICUS; submitted samples will be reviewed by a central pathologist to determine eligibility for the longitudinal cohort (i.e., an MDS, MDS/MPN, or ICUS diagnosis); should a discrepancy in diagnosis occur between the central review and study site, the study site will be notified to allow for additional information to be submitted to clarify the diagnosis; such notifications will not occur in real time, and are not intended to assist in patient care

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

ECOG-ACRIN Cancer Research Group

  • National Cancer Institute
Mikkael Aaron Sekeres, Principal Investigator

Trial Sites

U.S.A.

Florida
Jacksonville
Baptist MD Anderson Cancer Center
Edward J. Gorak
Ph: 904-202-7051
Edward J. Gorak
Principal Investigator
Illinois
Bloomington
Illinois CancerCare-Bloomington
James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org
James Lloyd Wade
Principal Investigator
Galesburg
Illinois CancerCare-Galesburg
James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org
James Lloyd Wade
Principal Investigator
Peoria
Illinois CancerCare-Peoria
James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org
James Lloyd Wade
Principal Investigator
Iowa
Des Moines
Iowa Methodist Medical Center
Robert J. Behrens
Ph: 515-282-2921
Robert J. Behrens
Principal Investigator
Medical Oncology and Hematology Associates-Des Moines
Robert J. Behrens
Ph: 515-282-2921
Robert J. Behrens
Principal Investigator
Kansas
Chanute
Cancer Center of Kansas - Chanute
Shaker R. Dakhil
Ph: 316-262-4467
Shaker R. Dakhil
Principal Investigator
Dodge City
Cancer Center of Kansas - Dodge City
Shaker R. Dakhil
Ph: 316-262-4467
Shaker R. Dakhil
Principal Investigator
Fort Scott
Cancer Center of Kansas - Fort Scott
Shaker R. Dakhil
Ph: 316-262-4467
Shaker R. Dakhil
Principal Investigator
Independence
Cancer Center of Kansas-Independence
Shaker R. Dakhil
Ph: 316-262-4467
Shaker R. Dakhil
Principal Investigator
Kingman
Cancer Center of Kansas-Kingman
Shaker R. Dakhil
Ph: 316-262-4467
Shaker R. Dakhil
Principal Investigator
Lawrence
Lawrence Memorial Hospital
Shaker R. Dakhil
Ph: 316-262-4467
Shaker R. Dakhil
Principal Investigator
Liberal
Cancer Center of Kansas-Liberal
Shaker R. Dakhil
Ph: 316-262-4467
Shaker R. Dakhil
Principal Investigator
Newton
Cancer Center of Kansas - Newton
Shaker R. Dakhil
Ph: 316-262-4467
Shaker R. Dakhil
Principal Investigator
Parsons
Cancer Center of Kansas - Parsons
Shaker R. Dakhil
Ph: 316-262-4467
Shaker R. Dakhil
Principal Investigator
Pratt
Cancer Center of Kansas - Pratt
Shaker R. Dakhil
Ph: 316-262-4467
Shaker R. Dakhil
Principal Investigator
Salina
Cancer Center of Kansas - Salina
Shaker R. Dakhil
Ph: 316-262-4467
Shaker R. Dakhil
Principal Investigator
Wellington
Cancer Center of Kansas - Wellington
Shaker R. Dakhil
Ph: 316-262-4467
Shaker R. Dakhil
Principal Investigator
Wichita
Associates In Womens Health
Shaker R. Dakhil
Ph: 316-262-4467
Shaker R. Dakhil
Principal Investigator
Cancer Center of Kansas - Main Office
Shaker R. Dakhil
Ph: 316-262-4467
Shaker R. Dakhil
Principal Investigator
Cancer Center of Kansas-Wichita Medical Arts Tower
Shaker R. Dakhil
Ph: 316-262-4467
Shaker R. Dakhil
Principal Investigator
Via Christi Regional Medical Center
Shaker R. Dakhil
Ph: 316-262-4467
Shaker R. Dakhil
Principal Investigator
Winfield
Cancer Center of Kansas - Winfield
Shaker R. Dakhil
Ph: 316-262-4467
Shaker R. Dakhil
Principal Investigator
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Amy Elizabeth DeZern
Ph: 410-955-8804
Email: jhcccro@jhmi.edu
Amy Elizabeth DeZern
Principal Investigator
Bel Air
Upper Chesapeake Medical Center
Ashkan Bahrani
Ph: 443-643-3010
Ashkan Bahrani
Principal Investigator
Michigan
Ann Arbor
Saint Joseph Mercy Hospital
Tareq Al Baghdadi
Ph: 734-712-4673
Tareq Al Baghdadi
Principal Investigator
Minnesota
Duluth
Saint Luke's Hospital of Duluth
Basem Said Goueli
Ph: 218-249-7825
Email: kdean@slhduluth.com
Basem Said Goueli
Principal Investigator
New York
Elmira
Arnot Ogden Medical Center/Falck Cancer Center
William Thomas Muuse
Ph: 607-271-7000
William Thomas Muuse
Principal Investigator
Ohio
Akron
Akron General Medical Center
Esther Hoogland Rehmus
Ph: 330-344-6348
Esther Hoogland Rehmus
Principal Investigator
Pennsylvania
Danville
Geisinger Medical Center
Joseph Joe Lukose Vadakara
Ph: 570-271-5251
Joseph Joe Lukose Vadakara
Principal Investigator
Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Joseph Joe Lukose Vadakara
Ph: 570-271-5251
Joseph Joe Lukose Vadakara
Principal Investigator
Lewisburg
Geisinger Medical Oncology-Lewisburg
Joseph Joe Lukose Vadakara
Ph: 570-271-5251
Joseph Joe Lukose Vadakara
Principal Investigator
Phoenixville
Phoenixville Hospital
Carl W. Sharer
Ph: 610-983-1908
Carl W. Sharer
Principal Investigator
Pottsville
Geisinger Medical Oncology-Pottsville
Joseph Joe Lukose Vadakara
Ph: 570-271-5251
Joseph Joe Lukose Vadakara
Principal Investigator
Wilkes-Barre
Geisinger Wyoming Valley/Henry Cancer Center
Joseph Joe Lukose Vadakara
Ph: 570-271-5251
Joseph Joe Lukose Vadakara
Principal Investigator
Williamsport
Susquehanna Cancer Center
Warren Lewis Robinson
Ph: 800-598-4282
Warren Lewis Robinson
Principal Investigator
South Carolina
Greenville
Saint Francis Cancer Center
Robert D. Siegel
Ph: 864-255-1713
Robert D. Siegel
Principal Investigator
Saint Francis Hospital
Robert D. Siegel
Ph: 864-255-1713
Robert D. Siegel
Principal Investigator
South Dakota
Aberdeen
Avera Cancer Institute-Aberdeen
Vinod Parameswaran
Ph: 888-634-7268
Email: oncregulatory@avera.org
Vinod Parameswaran
Principal Investigator
Washington
Auburn
MultiCare Auburn Medical Center
John A. Keech
Ph: 253-403-2394
John A. Keech
Principal Investigator
Gig Harbor
MultiCare Gig Harbor Medical Park
John A. Keech
Ph: 253-403-2394
John A. Keech
Principal Investigator
Puyallup
MultiCare Good Samaritan Hospital
John A. Keech
Ph: 253-403-2394
John A. Keech
Principal Investigator
Tacoma
MultiCare Tacoma General Hospital
John A. Keech
Ph: 253-403-2394
John A. Keech
Principal Investigator
Wisconsin
Green Bay
Green Bay Oncology at Saint Vincent Hospital
Brian Leslie Burnette
Ph: 800-432-6049
Brian Leslie Burnette
Principal Investigator
Green Bay Oncology Limited at Saint Mary's Hospital
Brian Leslie Burnette
Ph: 800-432-6049
Brian Leslie Burnette
Principal Investigator
Saint Mary's Hospital
Brian Leslie Burnette
Ph: 800-432-6049
Brian Leslie Burnette
Principal Investigator
Saint Vincent Hospital
Brian Leslie Burnette
Ph: 800-432-6049
Brian Leslie Burnette
Principal Investigator


Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.
NCT02775383 Clinical Trial - National Cancer Institute

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