このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

治療に対する例外的な応答者であるがん患者の組織サンプルにおける分子プロファイリング

2026年11月10日 更新者：National Cancer Institute (NCI)

優れたレスポンダーのパイロット研究: 優れたレスポンダーであるがん患者からの腫瘍の分子プロファイリング

This pilot research trial studies molecular profiling in tissue samples from patients with cancer who got better with treatment that didn't work for most other patients with the same disease. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to how well patients respond to treatment.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

PRIMARY OBJECTIVES:

I. To identify molecular indicators in malignant tissues from patients who were exceptional responders on clinical trials or standard systemic treatments using whole exome and/or targeted deep sequencing, as well as potentially other sequencing and other molecular characterization methods (if adequate tissue exists).

II. To explore associations between the identified molecular indicators and the putative mechanism of action of the treatment received by the patient.

III. To test the feasibility of identifying "exceptional responders", obtaining the relevant tumor and normal tissue and clinical data, and performing whole exome and/or targeted deep sequencing on these samples.

OUTLINE:

Previously collected tissue samples are analyzed via whole exome sequencing and/or targeted next generation sequencing (NGS) assay deep sequencing. Cases for which sufficient nucleic acid amounts are available will undergo additional analyses including whole genome sequencing, messenger ribonucleic acid (RNA) (mRNA)-sequencing, micro (miRNA) sequencing, promoter methylation analysis, and single nucleotide polymorphism (SNP) analysis.

研究の種類

観察的

入学 (実際)

170

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • California
      • Duarte、California、アメリカ、91010
        • City of Hope Comprehensive Cancer Center
      • Fresno、California、アメリカ、93720
        • Kaiser Permanente-Fresno
      • Oakland、California、アメリカ、94611
        • Kaiser Permanente-Oakland
      • Richmond、California、アメリカ、94801
        • Kaiser Permanente-Richmond
      • San Francisco、California、アメリカ、94158
        • UCSF Medical Center-Mission Bay
      • Santa Clara、California、アメリカ、95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Rosa、California、アメリカ、95403
        • Kaiser Permanente-Santa Rosa
      • Stockton、California、アメリカ、95210
        • Kaiser Permanente-Stockton
      • Walnut Creek、California、アメリカ、94596
        • Kaiser Permanente-Walnut Creek
    • Colorado
      • Aurora、Colorado、アメリカ、80045
        • UCHealth University of Colorado Hospital
      • Fort Collins、Colorado、アメリカ、80524
        • Poudre Valley Hospital
    • Connecticut
      • Greenwich、Connecticut、アメリカ、06830
        • Greenwich Hospital
    • Delaware
      • Newark、Delaware、アメリカ、19713
        • Helen F Graham Cancer Center
      • Newark、Delaware、アメリカ、19713
        • Medical Oncology Hematology Consultants PA
    • District of Columbia
      • Washington D.C.、District of Columbia、アメリカ、20016
        • Sibley Memorial Hospital
    • Georgia
      • Atlanta、Georgia、アメリカ、30322
        • Emory University Hospital/Winship Cancer Institute
      • Columbus、Georgia、アメリカ、31904
        • John B Amos Cancer Center
      • Valdosta、Georgia、アメリカ、31602
        • South Georgia Medical Center/Pearlman Cancer Center
    • Idaho
      • Boise、Idaho、アメリカ、83706
        • Saint Alphonsus Cancer Care Center-Boise
    • Illinois
      • Chicago、Illinois、アメリカ、60631
        • Presence Resurrection Medical Center
      • Chicago、Illinois、アメリカ、60612
        • Rush MD Anderson Cancer Center
      • Decatur、Illinois、アメリカ、62526
        • Decatur Memorial Hospital
      • Decatur、Illinois、アメリカ、62526
        • Cancer Care Specialists of Illinois - Decatur
      • Evanston、Illinois、アメリカ、60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Peoria、Illinois、アメリカ、61615
        • Illinois CancerCare-Peoria
      • Springfield、Illinois、アメリカ、62702
        • Springfield Clinic
    • Iowa
      • Cedar Rapids、Iowa、アメリカ、52402
        • Physicians' Clinic of Iowa PC
    • Maine
      • York Village、Maine、アメリカ、03909
        • York Hospital
    • Maryland
      • Bethesda、Maryland、アメリカ、20892
        • NCI - Center for Cancer Research
      • Bethesda、Maryland、アメリカ、20892
        • National Cancer Institute Developmental Therapeutics Clinic
    • Michigan
      • Ann Arbor、Michigan、アメリカ、48109
        • University of Michigan Rogel Cancer Center
      • Ann Arbor、Michigan、アメリカ、48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Brighton、Michigan、アメリカ、48114
        • Trinity Health Medical Center - Brighton
      • Detroit、Michigan、アメリカ、48201
        • Wayne State University/Karmanos Cancer Institute
      • Grand Rapids、Michigan、アメリカ、49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Marquette、Michigan、アメリカ、49855
        • UP Health System Marquette
      • Marquette、Michigan、アメリカ、49855
        • UP Health System Hematology Oncology Marquette
      • Southfield、Michigan、アメリカ、48075
        • Henry Ford Health Providence Southfield Hospital
    • Missouri
      • Cape Girardeau、Missouri、アメリカ、63703
        • Saint Francis Medical Center
      • Springfield、Missouri、アメリカ、65807
        • CoxHealth South Hospital
      • Springfield、Missouri、アメリカ、65804
        • Mercy Hospital Springfield
      • St Louis、Missouri、アメリカ、63110
        • Washington University School of Medicine
      • St Louis、Missouri、アメリカ、63131
        • Missouri Baptist Medical Center
      • St Louis、Missouri、アメリカ、63141
        • Mercy Hospital Saint Louis
    • Montana
      • Great Falls、Montana、アメリカ、59405
        • Benefis Sletten Cancer Institute
    • New Hampshire
      • Portsmouth、New Hampshire、アメリカ、03802
        • Portsmouth Regional Hospital
    • New Mexico
      • Albuquerque、New Mexico、アメリカ、87106
        • University of New Mexico Cancer Center
    • New York
      • Rochester、New York、アメリカ、14642
        • University of Rochester
    • North Carolina
      • Durham、North Carolina、アメリカ、27710
        • Duke University Medical Center
      • Winston-Salem、North Carolina、アメリカ、27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Fargo、North Dakota、アメリカ、58122
        • Sanford Roger Maris Cancer Center
    • Ohio
      • Columbus、Ohio、アメリカ、43214
        • Riverside Methodist Hospital
    • Oklahoma
      • Lawton、Oklahoma、アメリカ、73505
        • Cancer Centers of Southwest Oklahoma Research
      • Oklahoma City、Oklahoma、アメリカ、73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland、Oregon、アメリカ、97227
        • Kaiser Permanente Northwest
    • Pennsylvania
      • Phoenixville、Pennsylvania、アメリカ、19460
        • Reading Hospital McGlinn Cancer Institute at Phoenixville
      • West Chester、Pennsylvania、アメリカ、19380
        • Chester County Hospital
      • West Reading、Pennsylvania、アメリカ、19611
        • Reading Hospital
    • South Carolina
      • Greenville、South Carolina、アメリカ、29605
        • Prisma Health Cancer Institute - Faris
      • Greenville、South Carolina、アメリカ、29605
        • Prisma Health Cancer Institute - Butternut
      • Seneca、South Carolina、アメリカ、29672
        • Prisma Health Cancer Institute - Seneca
    • South Dakota
      • Sioux Falls、South Dakota、アメリカ、57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls、South Dakota、アメリカ、57104
        • Sanford Cancer Center Oncology Clinic
    • Tennessee
      • Kingsport、Tennessee、アメリカ、37660
        • Wellmont Holston Valley Hospital and Medical Center
    • Texas
      • Houston、Texas、アメリカ、77030
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
      • Houston、Texas、アメリカ、77030
        • Ben Taub General Hospital
      • San Antonio、Texas、アメリカ、78229
        • University of Texas Health Science Center at San Antonio
    • Utah
      • Salt Lake City、Utah、アメリカ、84112
        • Huntsman Cancer Institute/University of Utah
    • Virginia
      • Charlottesville、Virginia、アメリカ、22908
        • University of Virginia Cancer Center
    • West Virginia
      • Martinsburg、West Virginia、アメリカ、25401
        • WVUH-Berkely Medical Center
    • Wisconsin
      • Madison、Wisconsin、アメリカ、53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Summit、Wisconsin、アメリカ、53066
        • Aurora Medical Center in Summit
      • Waukesha、Wisconsin、アメリカ、53188
        • UW Cancer Center at ProHealth Care

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Patients with cancer participating in the Exceptional Cases Initiative

説明

Inclusion Criteria:

  • Documented exceptional response, defined as patients meeting the following criteria:

    • Complete response to a regimen in which complete response is expected in < 10% of similarly treated patients

    • Partial response (PR) > 6 months in a regimen in which PRs > 6 months are expected in < 10% of patients with similar disease treated with same or similar regimen

    • Complete response (CR) or PR of unusual duration, such that the internal review committee considers it to be an exceptional response; examples below:

      • PR of duration > 3 x the median expected PR duration (in cases where PR is expected in > 10% of patients with the same disease treated with the same regimen)
      • CR or duration > 3 x the median expected CR duration (in cases where CR may be seen in > 10% of patients with same disease treated with same regimen)
      • The observed duration of CR (or PR) is longer than expected for 90% of patients with same disease treated with same regimen

    • Note: it is not required that the patient be enrolled on a clinical trial when the exceptional response was observed

  • Reports of radiologic scans or other evidence documenting response will be submitted for review; cases where response is not assessable (e.g. adjuvant treatment) will not be eligible because the outcome can not be attributed to a specific treatment

  • Treatment history must be available, for prior treatment and for the drug to which the exceptional response occurred

  • Patient must meet consent criteria; this requires: (i) current exceptional responder (ER) consent by a living participant not lost to follow-up, (ii) prior consent for future research by a participant not known to be deceased, but lost to follow-up, or (iii) if patient is deceased and did not decline to participate in research at the time of tissue removal for any tissue that would be used in this study, then no consent is required

  • Tumor sample available that meets study requirements

  • Required tumor samples MUST exist and be able to be submitted; investigators wishing to submit samples must not have made agreements that would prohibit the free use of data from such samples; the National Cancer Institute (NCI) will provide investigators with a letter for the collaborator amending their existing agreement to allow for the case to be submitted

    • Tumor tissue from prior to administration of the drug to which the exceptional response occurred is required; ideally this sample will have been collected just prior to treatment, but other prior tissue will be considered; tissue may be fresh frozen or formalin-fixed paraffin embedded
    • Tumor tissue amount must be at least a core biopsy, and meet minimum specimen requirements

  • Encouraged: normal tissue sample: (optional): blood or other specimen source for germline sequencing

  • The tumor samples and clinical data submitted to the Exceptional Responders Database in database in Genotypes and Phenotypes (dbGaP) will need to have appropriate agreements in place to allow for the submission; the Exceptional Responders Database can accept clinical data and samples from cases enrolled on a Cancer Therapy Evaluation Program (CTEP) sponsored clinical trial and cases that were not enrolled on any clinical trial; if the response occurred on a trial that was not CTEP-sponsored, there are existing agreements between the submitting site and the pharmaceutical company; if existing agreements do not allow for the submission of sample and clinical data, the NCI will provide the investigators with a letter that allows the tissue to be used for the exceptional responders study if signed by the appropriate collaborator; the letter modifies the existing agreement to include the CTEP Intellectual Property (IP) Option language that would allow the case to be submitted to the Exceptional Responders Database; if the existing agreement cannot be modified and the letter cannot be signed, the proposed case will not be accepted; Note: as stated above, the patient does not need to have been enrolled on a clinical trial to be eligible for the exceptional responders study

Exclusion Criteria:

  • Patient's response did not meet criteria for an exceptional response
  • Patient's treatment regimen is expected to lead to CR or durable PR in > 10% of patients
  • Patient's duration of response is not > 3 x expected median length of response
  • Response not evaluable or not able to be attributed to systemic treatment (e.g. adjuvant treatment)
  • Patient refused consent for use of tissue for research activities included in the exceptional responders study
  • Tumor sample from prior to the exceptional response is not available, or does not meet quality metrics

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 観測モデル：CASE_CONTROL
  • 時間の展望：RETROSPECTIVE

コホートと介入

グループ/コホート
介入・治療
Ancillary-Correlative (molecular profiling)

Previously collected tissue samples are analyzed via whole exome sequencing and/or targeted NGS assay deep sequencing. Cases for which sufficient nucleic acid amounts are available will undergo additional analyses including whole genome sequencing, mRNA-sequencing, miRNA sequencing, promoter methylation analysis, and SNP analysis.
他の：Laboratory Biomarker Analysis

Undergo sequencing and SNP analysis

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Molecular features in tissue samples from patients who were exceptional responders
時間枠：Baseline

The molecular features of the tumors in the patients will be discernible as distinct to the tumor by comparison to (i) samples from normal tissue in the same patient and (ii) databases of similar data for normal and other tumor types.
Baseline
Putative mechanisms of action of the treatments that the patients received when they experienced their exceptional responses
時間枠：Baseline

The associations between identified molecular features and the putative mechanisms of action of the treatments that the patients received when they experienced their exceptional responses will be explored. Statistical analyses will be primarily descriptive.
Baseline
Number of cases identified as potential exceptional responders
時間枠：Baseline

Statistical analyses will be primarily descriptive.
Baseline
Percentage of identified potential cases confirmed to be exceptional responders
時間枠：Baseline

Statistical analyses will be primarily descriptive.
Baseline
Percentage of confirmed exceptional responders for which adequate tissue with appropriate informed consent is acquired
時間枠：Baseline

Statistical analyses will be primarily descriptive.
Baseline
Percentage of acquired cases with tissue for which at least the minimum molecular characterization is successfully obtained
時間枠：Baseline

Statistical analyses will be primarily descriptive.
Baseline
Percentage of molecularly characterized cases for which a Molecular Characterization report identified (without reference to the drug received by the patient) at least one feature judged to have potential therapeutic relevance
時間枠：Baseline

Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by an expert panel ("Panel") to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals.
Baseline
Percentage of cases with >= 1 feature on Molecular Characterization report that was judged to have potential therapeutic relevance to the specific class of drug the patient actually received when the exceptional response was experienced
時間枠：Baseline

Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by the Panel to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals.
Baseline
Percentage of cases with >= 1 feature that correlates with the mechanism of action of the specific grant to which the exceptional response occurred that was found after further analyzing the molecular profile data for relevant molecular abnormalities
時間枠：Baseline

Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by the Panel to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals.
Baseline

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

National Cancer Institute (NCI)

捜査官

  • 主任研究者：S. P Ivy、National Cancer Institute (NCI)

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2014年9月24日

一次修了 (実際)

2021年3月4日

研究の完了 (推定)

2027年4月30日

試験登録日

最初に提出

2014年9月16日

QC基準を満たした最初の提出物

2014年9月16日

最初の投稿 (推定)

2014年9月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月12日

QC基準を満たした最後の更新が送信されました

2026年11月10日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • NCI-2014-01585
  • UM1CA186704 (米国 NIH グラント/契約)
  • 9671 (その他の識別子：CTEP)
  • NCI-2014-01585 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
  • 9671 (その他の識別子：National Cancer Institute)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する