核医学部門で代謝放射線治療を受けた患者の臨床生物学的データベース (BCB RIV)
核医学部門で代謝放射線治療を受けた患者における将来の臨床生物学的データベースの確立
Development of a clinico-biological database allowing the provision of clinical data and corresponding biological materials to the medical and scientific community.
調査の概要
詳細な説明
Targeted radionuclide therapy (TRT) aims at delivering ionizing radiation specifically to tumors for therapeutic purposes. Different types of radionuclides can be used to deliver the radiation: beta minus emitters less (ie Iodine-131, Lutecium-177), alpha (Actinium-225, Radium-223) or Auger (Indium-111). They will target tumor cells either by natural tropism (iodine for thyroid cancer, for example) or by coupling to a specific vector (antibody, peptides or small molecules) recognizing particular tumor targets, such as somatostatin receptors in neuroendocrine tumors and certain meningiomas (177Lu-DOTATATE, Lutathera®) or prostate specific membrane antigen (PSMA) in metastatic prostate cancers (177Lu-PSMA-617, Pluvicto®).
Patients with thyroid cancer, prostate cancer, neuroendocrine tumors or SSTR positive tumours (like meningiomas) who should benefit form TRT may be included in this project. The clinical-biological database will help better understanding of the radiobiological mechanisms of action of ionizing radiations on both normal tissues and tumor cells and the psycho-oncological mechanisms involved in patients treated with TRT (only for ICM's patients). The collected data will help treatment optimization.
To meet these demands, the research must then integrate databases creation open to researchers and the ongoing evaluation of the impact of projects on the health of cancer patients. Integrated research associated with quality biological research is the guarantee of medical progress. The multidisciplinary structure around collections of biological resources will enable the various actors to harmonize not only the collection but also the sharing of their data with a view to making them available for medico-scientific projects at a regional and national dimension. The Clinical Biological Database (BCB) should be used to identify and characterize new molecular markers for better diagnosis and / or treatment. It should also permit to optimize the collection of all this information, their integration and their transversal exploitation by different research disciplines (epidemiological, fundamental, translational, clinical).
An ancillary study "IMMUNORIV" is associated to BCB RIV : The specific research aim is, first, to determine whether immune cell (lymphocytes and macrophages) scoring and characterization in metastatic thyroid cancer and NET samples at diagnosis predict the response to TRT. Second, a high-throughput approach will be used to determine i) the immune cell profile in blood samples from patients with NET, before and after TRT initiation, and ii) its possible correlation with the response to TRT. Third, using imaging techniques the possible correlation will be evaluated between tumor uptake/absorbed dose and response to TRT.
By monitoring the immune response during TRT, the IMMUNORIV project will allow to identify immune response-related biomarkers that may be modulated to improve TRT effect.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Aurore MOUSSION
- 電話番号：+33 0467613102
- メール：DRCI-icm105@icm.unicancer.fr
研究場所
-
-
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Montpellier、フランス、34298
- 募集
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
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コンタクト：
- Marc Ychou, MD, PhD
- 電話番号：33-4-6761-3066
- メール：marc.ychou@icm.unicancer.fr
-
コンタクト：
- Aurore MOUSSION
- 電話番号：0467613102
- メール：aurore.moussion@icm.unicancer.fr
-
Toulouse、フランス、31100
- 募集
- Institut Universitaire du Cancer de Toulouse
-
コンタクト：
- Lawrence DIERICKX, MD
- メール：Dierickx.Lawrence@iuct-oncopole.fr
-
-
Aquitaine
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Bordeaux、Aquitaine、フランス
- 募集
- Hopital Haut Lévêque
-
コンタクト：
- Elif HINDIE, MD
- メール：elif.hindie@chu-bordeaux.fr
-
-
Bouches Du Rhône
-
Marseille、Bouches Du Rhône、フランス
- まだ募集していません
- Hôpital LaTimone
-
コンタクト：
- David TAIEB, MD
- メール：David.TAIEB@ap-hm.fr
-
-
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
説明
Inclusion Criteria:
-
Age ≥ at 18 years old,
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Patient treated in the Nuclear Medicine Department for the treatment by metabolic radiotherapy,
-
Patient treated as part of his treatment for:
- thyroid cancer,
- a neuroendocrine tumor or any SSTR positive tumours (like meningiomas) receiving PRRT
- prostate cancer.
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Patient having accepted the complementary blood sample,
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Patient having given his informed, written and express consent.
Exclusion Criteria:
- Patient not affiliated to a social security scheme,
- Subject under tutelage, curatorship or safeguard of justice,
- Patient in an emergency situation
- Patient whose regular monitoring is a priori impossible for psychological, family, social or geographical reasons,
- Pregnant and / or breastfeeding woman
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
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Biological collection
Biological collection For all the patients include in the study : samples of blood samples collected before and during treatment. In parallel to this biological collection, standardized clinical data will be entered into a database Ancillary study : For metastatic thyroïd cancer and neuroendocrine tumor : anapath blocks of the initial diagnosis will be archived and dosimetric data will be collected for the cycle 1 For neuroendocrine tumor : blood sample additionnal will be realized at the cycle 1 (pre and post treatment) |
The biological collection will also include samples of blood samples collected before and during treatment. Tumor collection (diagnosis) will be done for thyroid cancer and neuroencrine |
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 |
|---|---|---|
|
Proportion of patients who gave their consent to participate in the study
時間枠：Until the study completion: 5 years
|
The proportion of patients who consent to participate in the study among the screened patients |
Until the study completion: 5 years
|
協力者と研究者
捜査官
- スタディチェア：Emmanuel DESHAYES, MD、Institut régional du Cancer Montpellier
出版物と役立つリンク
一般刊行物
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- Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum RP, Kunz P, Hobday T, Hendifar A, Oberg K, Sierra ML, Thevenet T, Margalet I, Ruszniewski P, Krenning E; NETTER-1 Study Group. Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 Trial. J Clin Oncol. 2018 Sep 1;36(25):2578-2584. doi: 10.1200/JCO.2018.78.5865. Epub 2018 Jun 7.
- Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fossa SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzen L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland OS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. doi: 10.1056/NEJMoa1213755.
- Schlumberger M, Catargi B, Borget I, Deandreis D, Zerdoud S, Bridji B, Bardet S, Leenhardt L, Bastie D, Schvartz C, Vera P, Morel O, Benisvy D, Bournaud C, Bonichon F, Dejax C, Toubert ME, Leboulleux S, Ricard M, Benhamou E; Tumeurs de la Thyroide Refractaires Network for the Essai Stimulation Ablation Equivalence Trial. Strategies of radioiodine ablation in patients with low-risk thyroid cancer. N Engl J Med. 2012 May 3;366(18):1663-73. doi: 10.1056/NEJMoa1108586.
- Pouget JP, Lozza C, Deshayes E, Boudousq V, Navarro-Teulon I. Introduction to radiobiology of targeted radionuclide therapy. Front Med (Lausanne). 2015 Mar 17;2:12. doi: 10.3389/fmed.2015.00012. eCollection 2015.
- Kumar C, Shetake N, Desai S, Kumar A, Samuel G, Pandey BN. Relevance of radiobiological concepts in radionuclide therapy of cancer. Int J Radiat Biol. 2016;92(4):173-86. doi: 10.3109/09553002.2016.1144944. Epub 2016 Feb 26.
- Gudkov SV, Shilyagina NY, Vodeneev VA, Zvyagin AV. Targeted Radionuclide Therapy of Human Tumors. Int J Mol Sci. 2015 Dec 28;17(1):33. doi: 10.3390/ijms17010033.
- Dizdarevic S, Tulchinsky M, McCready VR, Mihailovic J, Vinjamuri S, Buscombe JR, Lee ST, Frangos S, Sathekge M, Siraj Q, Choudhury P, Bom H, Franceschi M, Ugrinska A, Paez D, Hussain R, Mailman J, Luster M, Virgolini I; WARMTH Thyroid Group. The World Association of Radiopharmaceutical and Molecular Therapy position statement on the initial radioiodine therapy for differentiated thyroid carcinoma. World J Nucl Med. 2019 Apr-Jun;18(2):123-126. doi: 10.4103/wjnm.WJNM_117_18. No abstract available.
- Strosberg JR, Halfdanarson TR, Bellizzi AM, Chan JA, Dillon JS, Heaney AP, Kunz PL, O'Dorisio TM, Salem R, Segelov E, Howe JR, Pommier RF, Brendtro K, Bashir MA, Singh S, Soulen MC, Tang L, Zacks JS, Yao JC, Bergsland EK. The North American Neuroendocrine Tumor Society Consensus Guidelines for Surveillance and Medical Management of Midgut Neuroendocrine Tumors. Pancreas. 2017 Jul;46(6):707-714. doi: 10.1097/MPA.0000000000000850.
- Domenech A, Notta P, Benitez A, Ramal D, Rodriguez-Bel L, Massuet C, Martin-Comin J. [Evaluation of the anxiety state in patients receiving radioiodine treatment or who undergo a sentinel lymph node examination in the Nuclear Medicine Department]. Rev Esp Med Nucl. 2010 Mar-Apr;29(2):63-72. doi: 10.1016/j.remn.2009.12.009. Epub 2010 Feb 18. Spanish.
- Barbus E, Pestean C, Larg MI, Gabora K, Bonci EA, Badulescu C, Piciu A. Psychological impact of 131I radioprotection measures on thyroid cancer patients. Clujul Med. 2018 Oct;91(4):441-447. doi: 10.15386/cjmed-1042. Epub 2018 Oct 30.
- De Vincentis G, Frantellizzi V, Follacchio GA, Farcomeni A, Pani A, Samaritani R, Schinzari G, Santini D, Cortesi E. No evidence of association between psychological distress and pain relief in patients with bone metastases from castration-resistant prostate cancer treated with 223Radium. Eur J Cancer Care (Engl). 2019 Sep;28(5):e13112. doi: 10.1111/ecc.13112. Epub 2019 May 31.
- Schouten B, Avau B, Bekkering GTE, Vankrunkelsven P, Mebis J, Hellings J, Van Hecke A. Systematic screening and assessment of psychosocial well-being and care needs of people with cancer. Cochrane Database Syst Rev. 2019 Mar 26;3(3):CD012387. doi: 10.1002/14651858.CD012387.pub2.
- Pirl WF, Fann JR, Greer JA, Braun I, Deshields T, Fulcher C, Harvey E, Holland J, Kennedy V, Lazenby M, Wagner L, Underhill M, Walker DK, Zabora J, Zebrack B, Bardwell WA. Recommendations for the implementation of distress screening programs in cancer centers: report from the American Psychosocial Oncology Society (APOS), Association of Oncology Social Work (AOSW), and Oncology Nursing Society (ONS) joint task force. Cancer. 2014 Oct 1;120(19):2946-54. doi: 10.1002/cncr.28750. Epub 2014 May 2.
- Wu HX, Zhong H, Xu YD, Xu CP, Zhang Y, Zhang W. Psychological and behavioral intervention improves the quality of life and mental health of patients suffering from differentiated thyroid cancer treated with postoperative radioactive iodine-131. Neuropsychiatr Dis Treat. 2016 May 2;12:1055-60. doi: 10.2147/NDT.S105460. eCollection 2016.
- Shou J, Zhang Z, Lai Y, Chen Z, Huang J. Worse outcome in breast cancer with higher tumor-infiltrating FOXP3+ Tregs : a systematic review and meta-analysis. BMC Cancer. 2016 Aug 26;16(1):687. doi: 10.1186/s12885-016-2732-0.
- Sartor O, de Bono J, Chi KN, Fizazi K, Herrmann K, Rahbar K, Tagawa ST, Nordquist LT, Vaishampayan N, El-Haddad G, Park CH, Beer TM, Armour A, Perez-Contreras WJ, DeSilvio M, Kpamegan E, Gericke G, Messmann RA, Morris MJ, Krause BJ; VISION Investigators. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021 Sep 16;385(12):1091-1103. doi: 10.1056/NEJMoa2107322. Epub 2021 Jun 23.
- Constanzo J, Parach A, David T, Karam J, Bruchertseifer F, Morgenstern A, Jarlier M, Bardies M, Deshayes E, Gudin-de-Vallerin A, Boissiere-Michot F, Lopez-Crapez E, Pouget JP. MHC-I-Driven Antitumor Immunity Counterbalances Low Absorbed Doses of Radiopharmaceutical Therapy. J Nucl Med. 2025 May 1;66(5):785-792. doi: 10.2967/jnumed.124.268857.
- Hartrampf PE, Hanscheid H, Kertels O, Schirbel A, Kreissl MC, Flentje M, Sweeney RA, Buck AK, Polat B, Lapa C. Long-term results of multimodal peptide receptor radionuclide therapy and fractionated external beam radiotherapy for treatment of advanced symptomatic meningioma. Clin Transl Radiat Oncol. 2020 Mar 5;22:29-32. doi: 10.1016/j.ctro.2020.03.002. eCollection 2020 May.
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- Fizazi K, Morris MJ, Shore ND, Chi KN, Crosby M, de Bono JS, Herrmann K, Roubaud G, Nagarajah J, Fleming M, Lewis B, Nordquist L, Carnahan N, Ghebremariam S, Hertelendi M, Castellano D, Sartor O. Health-related quality of life, pain, and symptomatic skeletal events with [177Lu]Lu-PSMA-617 in patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): an open-label, randomised, phase 3 trial. Lancet Oncol. 2025 Jul;26(7):948-959. doi: 10.1016/S1470-2045(25)00189-5. Epub 2025 May 26.
便利なリンク
- <p>Health-related quality of life and pain outcomes with [177Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castrationresistant prostate cancer</p>
- <p>Phase III study of lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer</p>
- <p>Related Info</p>
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
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
- PROICM 2019-10 BRI
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 data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
IPD 共有時間枠
Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.
IPD 共有アクセス基準
The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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。