がん患者からの採血
ヒト被験者からの生体試料の取得
This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate. This study does not involve treatment.
Participants will have about 50 ml (3 tablespoonfuls) of blood drawn. Depending on their condition, patients may be invited to enroll in a clinical research study involving chemotherapy, radiotherapy, or surgery. Additional 40-ml blood samples may be drawn during the course of treatment.
調査の概要
詳細な説明
Background:
- Correlative studies performed on biospecimens of human subjects can be used to investigate the biology of solid tumors, inform the development of new strategies for treating those cancers, and evaluate these new therapeutic approaches. Specific areas of interest include, but are not limited to:
- the underlying mechanisms of tumor-specific immune response and suppression in cancer patients
- genetic and molecular profiling of tumors through circulating tumor cell (cTC), circulating DNA, and tissue analysis
- investigation of potential early diagnostic and prognostic indicators for solid tumors such as cTCs and miRNA expression of serum exosomes
- identification of mechanisms of drug-related adverse events and correlation with clinical parameters
- the role of commensal gut microbiota in both the innate and adaptive responses to tumors as well as with the use of anticancer agents
Objectives:
- Analyze biospecimens such as tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
- Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
- Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
Eligibility:
- Patients and healthy volunteers whose biospecimens are of interest to NIH investigators.
- 18 years of age or older.
Design:
- Cases will be evaluated by NCI or Interventional Radiology, NIH Clinical Center personnel. Blood, tissue, urine, saliva or other samples may be collected at the initial visit and at follow-up visits.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Jennifer L Marte
- 電話番号：(301) 496-7214
- メール：martej@mail.nih.gov
研究連絡先のバックアップ
- 名前：Michell J Manu, R.N.
- 電話番号：(240) 529-3415
- メール：michell.manu@nih.gov
研究場所
-
-
Maryland
-
Bethesda、Maryland、アメリカ、20892
- 募集
- National Institutes of Health Clinical Center
-
コンタクト：
- National Cancer Institute Referral Office
- 電話番号：888-624-1937
- メール：ncimo_referrals@mail.nih.gov
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Primary clinical; healthy volunteers may include NIH employees
説明
- INCLUSION CRITERIA:
Patients with a known or suspected malignancy and healthy volunteers 18 years of age and older are eligible.
Performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.
Ability to understand and the willingness to sign a written informed consent document.
INCLUSION FOR APHERESIS:
Note: Effective with Amendment CC, participants will no longer be asked to undergo apheresis. This content is being retained for historical reference.
Hemoglobin greater than or equal to 10 mg/dL and platelet count > 75,000/mm(3)
Weight greater than 25 kg
HIV negative
Prothrombin Time - within normal limits
Partial Thromboplastin Time - within normal limits
Medically indicated central line in place or adequate peripheral venous access
EXCLUSION CRITERIA:
None.
研究計画
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：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
|---|
|
Healthy Volunteers
Healthy volunteers 18 years of age and older |
|
Participants
Participants with cancer 18 years of age and older |
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 |
|---|---|---|
|
Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
時間枠：ongoing
|
Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis. |
ongoing
|
|
Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
時間枠：ongoing
|
Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes. |
ongoing
|
|
Collection of tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
時間枠：ongoing
|
Analyze tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects. |
ongoing
|
協力者と研究者
捜査官
- 主任研究者：Jennifer L Marte、National Cancer Institute (NCI)
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- 020179
- 02-C-0179
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
IPD 共有時間枠
Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
IPD 共有アクセス基準
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。