Study of Tissue and Blood Samples From Patients With High-Grade Glioma

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT01004887

Collaborator

National Cancer Institute (NCI) (NIH)

631

Enrollment

110

Locations

278.5

Actual Duration (Months)

5.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at tissue and blood samples from patients with high-grade glioma.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Other: diagnostic laboratory biomarker analysis

Detailed Description

OBJECTIVES:

To evaluate the diagnostic and prognostic relevance of various molecular, cytogenetic, and other tumor markers in high-grade glioma in paraffin-embedded tissue collected from patients enrolled in the Mayo Clinic or North Central Cancer Treatment Group (NCCTG) high-grade glioma trials conducted since 1979.
To evaluate alterations of specific chromosomes and chromosomal regions including 7, 9p, 10p, 10q, 13q, 17p, 17q, 19q, 22q, X, and Y using PCR analysis of microsatellite repeats and FISH.
To determine DNA ploidy by flow cytometric analysis.
To examine various markers of cellular proliferation and cellular function including flow cytometric determination of %S-phase, %G2M, and immunohistochemical evaluation of PCNA, Ki-67, and p53.
To evaluate additional markers identified by the Glioma Markers Network.
To compare the incidence of markers in the major histologic subtypes (anaplastic astrocytoma [AA], anaplastic oligoastrocytoma [AOA], glioblastoma multiforme [GBM]) and to assess their correlation in the total group, as well as within each of these subtypes.
To compare the ploidy determinations by FISH and flow cytometry.

OUTLINE: Paraffin-embedded tissue and peripheral blood samples, previously or currently collected from clinical trials participants at the time she/he enrolled in the trial, are evaluated for as many markers as possible, changes in cytogenic and molecular genetic tumor markers, frequency distributions of all tumor markers and histological and clinical variables by polymerase chain reaction, IHC, flow cytometry, and FISH analysis.

Study Design

Study Type:

Observational

Actual Enrollment :

631 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Diagnostic And Prognostic Markers In High-Grade Glioma

Actual Study Start Date :

Nov 1, 1995

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Jan 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Single group Patients with newly diagnosed high-grade gliomas participating in NCCTG/Alliance or Mayo protocols. Previously collected blood and tissue samples are analyzed via PCR, IHC, flow cytometry, and FISH.	Other: diagnostic laboratory biomarker analysis

Arm

Intervention/Treatment

Single group

Patients with newly diagnosed high-grade gliomas participating in NCCTG/Alliance or Mayo protocols. Previously collected blood and tissue samples are analyzed via PCR, IHC, flow cytometry, and FISH.

Other: diagnostic laboratory biomarker analysis

Outcome Measures

Primary Outcome Measures

time to progression [baseline]
survival [baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Patients with newly diagnosed high-grade gliomas
Patients participating in NCCTG/Alliance or Mayo protocols
Willing to provide mandatory blood and tissue samples for research purposes; note: 15 unstained slides may be submitted in place of a tissue block

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Scottsdale	Scottsdale	Arizona	United States	85259-5499
2	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
3	Mayo Clinic - Jacksonville	Jacksonville	Florida	United States	32224
4	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	Idaho	United States	83706
5	Illinois CancerCare - Bloomington	Bloomington	Illinois	United States	61701
6	St. Joseph Medical Center	Bloomington	Illinois	United States	61701
7	Graham Hospital	Canton	Illinois	United States	61520
8	Illinois CancerCare - Canton	Canton	Illinois	United States	61520
9	Illinois CancerCare - Carthage	Carthage	Illinois	United States	62321
10	Memorial Hospital	Carthage	Illinois	United States	62321
11	Eureka Community Hospital	Eureka	Illinois	United States	61530
12	Illinois CancerCare - Eureka	Eureka	Illinois	United States	61530
13	Galesburg Clinic, PC	Galesburg	Illinois	United States	61401
14	Illinois CancerCare - Galesburg	Galesburg	Illinois	United States	61401
15	Illinois CancerCare - Havana	Havana	Illinois	United States	62644
16	Mason District Hospital	Havana	Illinois	United States	62644
17	Illinois CancerCare - Kewanee Clinic	Kewanee	Illinois	United States	61443
18	Illinois CancerCare - Macomb	Macomb	Illinois	United States	61455
19	McDonough District Hospital	Macomb	Illinois	United States	61455
20	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus	Moline	Illinois	United States	61265
21		Moline	Illinois	United States	61265
22	Illinois CancerCare - Monmouth	Monmouth	Illinois	United States	61462
23	OSF Holy Family Medical Center	Monmouth	Illinois	United States	61462
24	BroMenn Regional Medical Center	Normal	Illinois	United States	61761
25	Community Cancer Center	Normal	Illinois	United States	61761
26	Illinois CancerCare - Community Cancer Center	Normal	Illinois	United States	61761
27	Community Hospital of Ottawa	Ottawa	Illinois	United States	61350
28	Oncology Hematology Associates of Central Illinois, PC - Ottawa	Ottawa	Illinois	United States	61350
29	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois	United States	61554
30	Illinois CancerCare - Pekin	Pekin	Illinois	United States	61603
31	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61615
32	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois	United States	61615
33	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
34	OSF St. Francis Medical Center	Peoria	Illinois	United States	61637
35	Illinois CancerCare - Peru	Peru	Illinois	United States	61354
36	Illinois Valley Community Hospital	Peru	Illinois	United States	61354
37	Illinois CancerCare - Princeton	Princeton	Illinois	United States	61356
38	Perry Memorial Hospital	Princeton	Illinois	United States	61356
39	Illinois CancerCare - Spring Valley	Spring Valley	Illinois	United States	61362
40		Bettendorf	Iowa	United States	52722
41	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa	United States	52403
42	Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
43	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
44	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51102
45	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
46	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
47	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
48	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
49	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
50	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
51	Hurley Medical Center	Flint	Michigan	United States	48503
52	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
53	Foote Memorial Hospital	Jackson	Michigan	United States	49201
54	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
55	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
56	Community Cancer Center of Monroe	Monroe	Michigan	United States	48162
57	Mercy Memorial Hospital - Monroe	Monroe	Michigan	United States	48162
58	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
59	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
60	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
61	St. John Macomb Hospital	Warren	Michigan	United States	48093
62	MeritCare Bemidji	Bemidji	Minnesota	United States	56601
63	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota	United States	55805-1983
64	CCOP - Duluth	Duluth	Minnesota	United States	55805
65	Miller - Dwan Medical Center	Duluth	Minnesota	United States	55805
66	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
67	CentraCare Clinic - River Campus	Saint Cloud	Minnesota	United States	56303
68	Coborn Cancer Center	Saint Cloud	Minnesota	United States	56303
69	Mount Sinai Medical Center	New York	New York	United States	10029
70	Bismarck Cancer Center	Bismarck	North Dakota	United States	58501
71	Medcenter One Hospital Cancer Care Center	Bismarck	North Dakota	United States	58501
72	Mid Dakota Clinic, PC	Bismarck	North Dakota	United States	58501
73	St. Alexius Medical Center Cancer Center	Bismarck	North Dakota	United States	58502
74	MeritCare Broadway	Fargo	North Dakota	United States	58102
75	CCOP - MeritCare Hospital	Fargo	North Dakota	United States	58122
76	Roger Maris Cancer Center at MeritCare Hospital	Fargo	North Dakota	United States	58122
77	Wood County Oncology Center	Bowling Green	Ohio	United States	43402
78	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
79	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
80	CCOP - Columbus	Columbus	Ohio	United States	43215
81	Grant Medical Center Cancer Care	Columbus	Ohio	United States	43215
82	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
83	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
84	Grady Memorial Hospital	Delaware	Ohio	United States	43015
85	Community Cancer Center	Elyria	Ohio	United States	44035
86	Hematology Oncology Center	Elyria	Ohio	United States	44035
87	Fairfield Medical Center	Lancaster	Ohio	United States	43130
88	Lima Memorial Hospital	Lima	Ohio	United States	45804
89	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
90	Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537-1839
91	Knox Community Hospital	Mount Vernon	Ohio	United States	43050
92	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
93	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
94	Toledo Clinic - Oregon	Oregon	Ohio	United States	43616
95	Southern Ohio Medical Center Cancer Center	Portsmouth	Ohio	United States	45662
96	North Coast Cancer Care, Incorporated	Sandusky	Ohio	United States	44870
97	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
98	Flower Hospital Cancer Center	Sylvania	Ohio	United States	43560
99	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
100	Toledo Hospital	Toledo	Ohio	United States	43606
101	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
102	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
103	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43617
104	St. Anne Mercy Hospital	Toledo	Ohio	United States	43623
105	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
106	Fulton County Health Center	Wauseon	Ohio	United States	43567
107	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio	United States	43081
108	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
109	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57701
110	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia	United States	22401