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Borderline Ovarian Clear Cell TumorNCT00897442

Collecting Tumor Samples From Patients With Gynecological Tumors

An observational study of Borderline Ovarian Clear Cell Tumor and Borderline Ovarian Serous Tumor, run by Gynecologic Oncology Group at 187 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This laboratory study is collecting tumor tissue and blood samples from patients with gynecologic tumors. Collecting and storing samples of tumor tissue and blood from patients with cancer to study in the laboratory may help in the study of cancer. Read more about this study

Who is it for?
Any age, women only
What is being tested?
Laboratory Biomarker Analysis
How many people
275 participants
Where
187 sitesUnited States
Study dates
Jun 1992to Jan 2016
Phase
Observational
Are there results?
None posted in the registry

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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients With Gynecological Tumors

Who may be able to join

  • Any of the following:
  • Patients who have had gynecologic tissue removed during surgery to diagnosis, treat, monitor, and/or prevent primary, persistent, or recurrent gynecologic cancer of the ovary, peritoneum, fallopian tube, cervix, uterine corpus, vagina, or vulva, meeting at least one of the following criteria:
  • Group A: Women who underwent surgery, were diagnosed with a primary gynecologic malignancy of the ovary, cervix, uterine corpus, or vulva, and have primary tumor, normal tissue, and blood available for submission for this protocol
  • Patients with ovarian cancer including all stages, grades, and common epithelial cell types
  • Invasive cancers and serous and mucinous borderline tumors of low malignant potential are allowed
  • At least 1 gram of frozen primary tumor tissue must be submitted for this protocol for patients with FIGO stage III or IV epithelial ovarian cancer
Show all 27Show fewer
  • Patients with an invasive malignancy of the cervix or uterine corpus including all stages, grades, and common cell types
  • Patients with squamous cell carcinoma of the vulva
  • Group B: Women who underwent surgery and were diagnosed with a rare gynecologic malignancy of the ovary, peritoneum, fallopian tube, cervix, uterine corpus, vagina, vulva, a gestational trophoblastic tumor, or a tumor arising in endometriosis, and have tumor tissue available for submission for this protocol
  • Patients with a rare gynecologic malignancy of the ovary including malignant germ cell tumors; sex cord-stromal tumors; malignant mixed mesodermal tumors; clear cell, mucinous, small cell, or transitional cell carcinomas; malignant Brenner tumors; or borderline tumors of low malignant potential (except serous and mucinous)
  • Patients with a rare gynecologic malignancy of the peritoneum, including primary peritoneal cancer or mesothelioma
  • Patients with carcinoma of the fallopian tube
  • Patients with a rare gynecologic malignancy of the cervix including verrucous, small cell, clear cell, serous, or adenoid cystic carcinomas; carcinoid tumors; malignant mixed mesodermal tumors; or leiomyosarcoma
  • Patients with a rare gynecologic malignancy of the uterine corpus including leiomyosarcoma; malignant mixed mesodermal tumors; endometrial stromal sarcomas; smooth muscle tumors of unknown malignant potential; or clear cell or small cell carcinomas
  • Patients with a rare gynecologic malignancy of the vagina including verrucous or clear cell carcinomas; melanoma; embryonal rhabdomyosarcoma; or endodermal sinus tumor
  • Patients with a rare gynecologic malignancy of the vulva including verrucous carcinoma; melanoma; aggressive angiomyxoma; sarcoma; malignant Paget's disease; or Bartholin gland carcinoma
  • Patients with a gestational trophoblastic tumor
  • Patients with a tumor arising in endometriosis
  • Group C: Women who underwent prophylactic oophorectomy and have at least 1 gram of ovarian tissue and blood available for submission for this protocol
  • Group D: Women who underwent surgery to monitor or treat a persistent or recurrent gynecologic malignancy of the ovary, peritoneum, fallopian tube, cervix, uterine corpus, vagina, or vulva, and have persistent or recurrent tumor, normal tissue, and blood available for submission for this protocol
  • Concurrent primary cancers are allowed
  • No benign cystic tumors of the ovary, including cystic epithelial tumors and mature cystic teratomas
  • Prior cytotoxic chemotherapy allowed
  • Prior hormonal therapy allowed
  • Prior radiotherapy allowed
  • Prior surgery allowed
  • No more than 6 weeks after prior surgery

Who cannot join

None listed.

Trial locations and contacts

187 sites in 1 country.

187 sites in 1 country

United States187 sites
  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Akron General Medical Center

    Akron, Ohio, 44307

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Our Lady Bellefonte Hospital

    Ashland, Kentucky, 41101

  • Northside Hospital

    Atlanta, Georgia, 30342

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Colorado Gynecologic Oncology Group

    Aurora, Colorado, 80010

  • University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • University Medical Center Brackenridge

    Austin, Texas, 78701

  • The Union Memorial Hospital

    Baltimore, Maryland, 21218

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • Woman's Hospital

    Baton Rouge, Louisiana, 70817

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Chattanooga's Program in Women's Oncology

    Chattanooga, Tennessee, 37403

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • Zale Lipshy University Hospital

    Dallas, Texas, 75235

  • Clements University Hospital

    Dallas, Texas, 75390

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa-Wide Oncology Research Coalition NCORP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin, 54701

  • Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Saint Elizabeth Medical Center South

    Edgewood, Kentucky, 41017

  • Highlands Oncology Group PA - Fayetteville

    Fayetteville, Arkansas, 72703

  • Washington Regional Medical Center - Fayetteville

    Fayetteville, Arkansas, 72703

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Florida Gynecologic Oncology

    Fort Myers, Florida, 33905

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Gynecologic Oncology of West Michigan PLLC

    Grand Rapids, Michigan, 49546

  • Gynecologic Oncology Network

    Greenville, North Carolina, 27834

  • Pitt County Memorial Hosp Inc.

    Greenville, North Carolina, 27834

  • East Carolina University

    Greenville, North Carolina, 27858

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

  • Hackensack University Medical CCOP

    Hackensack, New Jersey, 07601

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Virginia Oncology Associates-Hampton

    Hampton, Virginia, 23666

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • The Methodist Hospital System

    Houston, Texas, 77030

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Saint Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Saint Dominic-Jackson Memorial Hospital

    Jackson, Mississippi, 39216

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • East Tennessee State University

    Johnson City, Tennessee, 37614-0054

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • Keesler Medical Center

    Kessler Air Force Base, Mississippi, 39534

  • Southeast Gynecologic Oncology Associates

    Knoxville, Tennessee, 37917

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • Marshfield Clinic - Ladysmith Center

    Ladysmith, Wisconsin, 54848

  • Saint Clare Hospital

    Lakewood, Washington, 98499

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Long Beach Memorial Medical Center-Todd Cancer Institute

    Long Beach, California, 90806

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

  • Norton Hospital Pavilion and Medical Campus

    Louisville, Kentucky, 40202

  • Covenant Medical Center-Lakeside

    Lubbock, Texas, 79410

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Saint Joseph's Hospital

    Marshfield, Wisconsin, 54449

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38163

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Winthrop University Hospital

    Mineola, New York, 11501

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Meharry Medical College

    Nashville, Tennessee, 37208

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Yale University

    New Haven, Connecticut, 06520

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University/Herbert Irving Cancer Center

    New York, New York, 10032

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Providence - Saint Peter Hospital

    Olympia, Washington, 98506-5166

  • Capital Medical Center

    Olympia, Washington, 98507

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Stanford Cancer Institute

    Palo Alto, California, 94304

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • FirstHealth of the Carolinas-Moore Regional Hosiptal

    Pinehurst, North Carolina, 28374

  • UPMC-Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • Maine Medical Center-Bramhall Campus

    Portland, Maine, 04102

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Compass Oncology Rose Quarter

    Portland, Oregon, 97227

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • MultiCare Good Samaritan Hospital

    Puyallup, Washington, 98372

  • Black Hills Obstetrics and Gynecology

    Rapid City, South Dakota, 57701

  • Marshfield Clinic at James Beck Cancer Center

    Rhinelander, Wisconsin, 54501

  • Marshfield Clinic-Rice Lake Center

    Rice Lake, Wisconsin, 54868

  • Carilion Clinic Gynecological Oncology

    Roanoke, Virginia, 24016

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • UCSF Medical Center-Mount Zion

    San Francisco, California, 94115

  • Memorial University Medical Center

    Savannah, Georgia, 31404

  • Virginia Mason CCOP

    Seattle, Washington, 98101

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Pacific Gynecology Specialists

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122-4307

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • CHRISTUS Highland Medical Center

    Shreveport, Louisiana, 71105

  • Sanford Cancer Center-Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • Greenville Health System Cancer Institute-Spartanburg

    Spartanburg, South Carolina, 29307

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Cancer Research for the Ozarks NCORP

    Springfield, Missouri, 65804

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Saint Louis University Hospital

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Marshfield Clinic Cancer Care at Saint Michael's Hospital

    Stevens Point, Wisconsin, 54481

  • Saint Michael's Hospital

    Stevens Point, Wisconsin, 54481

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Olive View-University of California Los Angeles Medical Center

    Sylmar, California, 91342

  • MultiCare Allenmore Hospital

    Tacoma, Washington, 98405

  • MultiCare Tacoma General Hospital

    Tacoma, Washington, 98405

  • Northwest Medical Specialties PLLC

    Tacoma, Washington, 98405

  • Northwest NCI Community Oncology Research Program

    Tacoma, Washington, 98405

  • Saint Joseph Medical Center

    Tacoma, Washington, 98405

  • Multicare Health System

    Tacoma, Washington, 98415

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

  • Cancer Care Associates-Midtown

    Tulsa, Oklahoma, 74104

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • Marshfield Clinic-Wausau Center

    Wausau, Wisconsin, 54401

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Methodist West Hospital

    West Des Moines, Iowa, 50266-7700

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

  • Diagnostic and Treatment Center

    Weston, Wisconsin, 54476

  • Marshfield Clinic - Weston Center

    Weston, Wisconsin, 54476

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin, 54494

  • University of Massachusetts Memorial Health Care

    Worcester, Massachusetts, 01605

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: Acquisition of Human Gynecologic Specimens to be Used in Studying the Causes, Diagnosis, Prevention and Treatment of Cancer

This laboratory study is collecting tumor tissue and blood samples from patients with gynecologic tumors. Collecting and storing samples of tumor tissue and blood from patients with cancer to study in the laboratory may help in the study of cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To collect gynecologic tissue and blood from participating Gynecologic Oncology Group (GOG) institutions.

II. To provide a repository for long-term storage of gynecologic tissue and blood that will be used in studies designed to better understand the molecular biology of gynecologic tumors.

III. To make available, through the GOG Tissue Bank, tissue and blood for proposed projects conducted by GOG and non-GOG investigators.

OUTLINE:

Snap frozen tumor tissue, OCT molds of tumor tissue, formalin-preserved tumor tissue, buffy coat-prepared tumor tissue, and blood samples are collected and stored in the repository. Patient information is kept confidential, and patients are not informed of any research/test results from use of their tissues.

Being tested
Laboratory Biomarker Analysis
Medical subject headings
Ovarian Germ Cell Cancer, Sarcoma, Endometrial Stromal, Gestational Trophoblastic Disease, Mesothelioma, Malignant, Melanoma, Brenner Tumor, Uterine Cervical Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT00897442
Study groupRoleWhat they receive
Ancillary-Correlative (biomarker sampling and analysis)Snap frozen tumor tissue, OCT molds of tumor tissue, formalin-preserved tumor tissue, buffy coat-prepared tumor tissue, and blood samples are collected and stored in the repository. Patient information is kept confidential, and patients are not informed of any research/test results from use of their tissues.
Receives: Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Collection of gynecological tumor specimens and serum from patients at GOG institutions

    Measured: Baseline

  2. Create a repository for long-term storage of these specimens

    Measured: Baseline

  3. Make available tissue and blood for proposed projects

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2009 (estimated)
  2. Study startJun 1992
  3. Primary completionJan 2016

Resources

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
Cohort
Time perspective
Prospective
Enrolment
275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00897442
Sponsor's protocol ID
GOG-0136
Other IDs
NCI-2009-00577, GOG-136, CDR0000078647, GOG-0136, GOG-0136, U10CA180868
Status last verified
Oct 2016
First submitted
9 May 2009
Last updated
28 Oct 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Borderline Ovarian Clear Cell Tumor and Borderline Ovarian Serous Tumor, run by Gynecologic Oncology Group at 187 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 187 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Collection of gynecological tumor specimens and serum from patients at GOG institutions (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.

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