Relationship Between Gut Microbiome and Adjuvant Chemotherapy in Patients With Early Breast Cancer
A Prospective Cohort Study of Relationship Between Gut Microbiome and Adjuvant Chemotherapy in Patients With Early Breast Cancer
Breast cancer is the most common cause of cancer death in women. Adjuvant chemotherapy significantly reduces the risk of recurrence of high-risk breast cancer. However, about 30% of patients still have distant metastasis or local recurrence after chemotherapy. Moreover, 60% of patients had 3-4 degrees of adverse drug reactions during chemotherapy.
The purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.
調査の概要
詳細な説明
Breast cancer is the most common cause of cancer death in women. Adjuvant chemotherapy significantly reduces the risk of recurrence of high-risk breast cancer. However, about 30% of patients still have distant metastasis or local recurrence after chemotherapy. Moreover, 60% of patients had 3-4 degrees of adverse drug reactions during chemotherapy.
The human gut microbiota have been considered the most important microecosystem living in symbiosis with the body. It is identified as a crucial determinant in cancer occurrence and development . Besides, Gut microbial alterations may influence the therapy efficacy and adverse drug event.
We collect the fresh tail stool sample 24h before adjuvant chemotherapy and 24h after adjuvant chemotherapy then the composition of intestinal microbiota and subsequent short-term alterations are analysed by 16srRNA sequencing.The purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、510060
- Sun Yat-Sen University Cancer Center
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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
説明
Inclusion Criteria:
- Histologically diagnosed stage I-III breast cancer;
- Plan to receive adjuvant chemotherapy in our hospital;
- Sign the informed consent;
- Good compliance and willing to follow up.
Exclusion Criteria:
- Those who have started receiving adjuvant chemotherapy;
- Chemotherapy contraindications;
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
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 |
---|---|---|
The incidence of chemotherapy related adverse reaction
時間枠:1 years
|
chemotherapy related adverse reaction are assessed by CTCAE protocol
|
1 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
disease free survival
時間枠:5years
|
the length of time after surgery during which no breast cancer is found
|
5years
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (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 (実際)
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
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。
乳がんの臨床試験
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