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治験 NCT03424915（対象：乳癌）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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メモリアル・スローン・ケタリングがんセンターExercise, Fitness and Tumor Profiling in Breast Cancer Patients
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT03424915 は 観察研究 臨床試験 で、乳癌 に関するものです。現在は 実施中／登録終了 で、2018年1月31日 から開始しています。42 名の参加者 の募集が計画されています。この治験は メモリアル・スローン・ケタリングがんセンター によって主催され、2026年1月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年7月4日 です。
概要
This study is designed to find out how engaging in regular exercise (or not) alters the biology of breast tumors as well as the normal tissue (if available) surrounding the tumor. The investigators hope that findings from this initial study will guide the design of future studies to examine how changes in exercise alter breast tumor biology.
公式タイトル
Integrative Profiling of Primary Breast Cancer on the Basis of Divergent Exercise Exposure
疾患／病気
乳癌その他の研究識別子
- 18-058
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
Regular exercisers and non-exercising groups who have been diagnosed with breast cancer There is no treatment on this study, it is a onetime assessment. exercisers: ≥120 minutes of vigorous-intensity aerobic exercise;There is no treatment on this study, it is a onetime assessment. non-exercisers: ≤ 30 minutes of moderate-intensity exercise per week. | Harvard Health Professionals Survey Participants will be asked a series of questions (using a validated questionnaire) to assess self-reported exercise exposure over the past 12 months. 採血 Participant will provide a blood sample CPET Procedures CPET with 12-lead ECG 便サンプル Research stool sample (within ±1 week of surgery), if possible Research Tissue Sampling Sample of the tumor and normal breast tissue may be taken from the tissue removed during breast cancer surgery if there is enough tissue left over for research testing. |
Regular exercisers who are at high risk of developing breast cancer ≥120 minutes of vigorous-intensity aerobic exercise; | Harvard Health Professionals Survey Participants will be asked a series of questions (using a validated questionnaire) to assess self-reported exercise exposure over the past 12 months. Research Tissue Sampling Sample of the tumor and normal breast tissue may be taken from the tissue removed during breast cancer surgery if there is enough tissue left over for research testing. |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
differences in DNA somatic mutational profile | Eight-μm-thick representative sections of the fresh-frozen sample will be microdissected with a needle under a stereomicroscope (Olympus SZ61), to ensure \>70% of tumor cell content as previously described.(36) Matched germline DNA will be microdissected from adjacent normal breast tissue (if available) for each case; to avoid the possibility of morphologically appearing non-neoplastic cells harboring somatic mutations; we will prioritize the microdissection of stromal cells and avoid normal breast ducts and lobules. | 2 years |
differences in RNA sequencing | The initial analysis will focus on immune signatures (i.e., immune activation, as well as preexisting immune and related signatures) characterization using RNA-seq | 2 years |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
21 Years
対象性別
女性
Cohort 1: Breast Cancer Patients
- Ages 21-80 years
- Female
- Histologically confirmed ER receptor positive (>1% staining), HER2 negative (FISH ratio <1.8), untreated operable breast cancer
- Stage I to II disease
- Scheduled for surgical resection by any type of mastectomy or lumpectomy at MSK
- Tumor size ≥1cm by preoperative imaging or physical examination
- Categorization into self-reported exercise history exposure classifications as follows: (1) exercising: ≥120 minutes of vigorous-intensity exercise/wk for the past 12 months, and (2) sedentary (non-exercising): ≤ 30 minutes of moderate-intensity exercise/week for the past months using the Harvard Health Professionals survey.(34)
- Ability to read and understand English
- Willing and able to comply with requirements of the protocol
Cohort 2: High-Risk Patients
Women at high-risk of breast cancer, as defined by one of the following:
- Cytologically confirmed atypical hyperplasia
- confirmed LCIS
- Being a carrier for BRCA1 and/or BRCA2
- Predicted lifetime risk of breast cancer >20% based on family history
- Predicted 10-year risk of breast cancer of ≥2.31%
- Predicted 5-year risk of breast cancer ≥1.67%
Aged 21-80 years old
If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study.
- Women <50 years old of child-bearing potential must have a negative pregnancy test (urine HCG or serum) within 14 days of enrollment.
Cohort 1:
Received any form of neoadjuvant treatment
Presence of any other concurrent, actively treated malignancy
Presence of metastatic disease
If performing a CPET, any of the following contraindications:
- Acute myocardial infarction within 3-5 days of any planned study procedures;
- Unstable angina
- Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
- Recurrent syncope
- Active endocarditis
- Acute myocarditis or pericarditis
- Symptomatic severe aortic stenosis
- Uncontrolled heart failure
- Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
- Thrombosis of lower extremities
- Suspected dissecting aneurysm
- Uncontrolled asthma
- Pulmonary edema
- Respiratory failure
- Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis).
Mental impairment leading to inability to cooperate
If performing a CPET, room air desaturation at rest ≤ 85%
Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the study.
Cohort 2:
Use of any selective estrogen receptor modulator or aromatase inhibitor within 6 months of consent, including, but not limited to: tamoxifen, raloxifene, arzoxifene, acolbifene, anastrozole, exemestane, and letrozole.
Enrollment on an interventional investigational study
Bilateral breast implants
History of any of the following:
- Invasive breast cancer
- DCIS
Any current invasive cancer diagnosis
Metastatic malignancy of any kind
If performing a CPET, any of the following contraindications:
- Acute myocardial infarction within 3-5 days of any planned study procedures;
- Unstable angina
- Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
- Recurrent syncope
- Active endocarditis
- Acute myocarditis or pericarditis
- Symptomatic severe aortic stenosis
- Uncontrolled heart failure
- Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
- Thrombosis of lower extremities
- Suspected dissecting aneurysm
- Uncontrolled asthma
- Pulmonary edema
- Respiratory failure
- Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis).
Mental impairment leading to inability to cooperate
If performing a CPET, room air desaturation at rest ≤ 85%
Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the core biopsy or the study.
メモリアル・スローン・ケタリングがんセンター737 件のアクティブな治験を探索連絡先情報がありません。
7 1カ国の場所
New Jersey
Memorial Sloan Kettering Basking Ridge (Consent and Follow-up), Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent and Follow-up), Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent and Follow-up), Montvale, New Jersey, 07645, United States
New York
Memorial Sloan Kettering Commack (Consent and Follow-up), Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent and Follow-up), Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (Consent and Follow-up), New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent and Follow-up), Uniondale, New York, 11553, United States