핵의학과에서 대사 방사선 치료를 받는 환자의 임상생물학적 데이터베이스 (BCB RIV)
핵의학과 대사방사선치료 환자의 전향적 임상생물학적 데이터베이스 구축 원문보기 KCI 원문보기 인용
Development of a clinico-biological database allowing the provision of clinical data and corresponding biological materials to the medical and scientific community.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Aurore MOUSSION
- 전화번호: +33 0467613102
- 이메일: DRCI-icm105@icm.unicancer.fr
연구 장소
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Montpellier, 프랑스, 34298
- 모병
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
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연락하다:
- Marc Ychou, MD, PhD
- 전화번호: 33-4-6761-3066
- 이메일: marc.ychou@icm.unicancer.fr
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연락하다:
- Aurore MOUSSION
- 전화번호: 0467613102
- 이메일: aurore.moussion@icm.unicancer.fr
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Toulouse, 프랑스, 31100
- 모병
- Institut Universitaire du Cancer de Toulouse
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연락하다:
- Lawrence DIERICKX, MD
- 이메일: Dierickx.Lawrence@iuct-oncopole.fr
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Aquitaine
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Bordeaux, Aquitaine, 프랑스
- 모병
- Hopital Haut Lévêque
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연락하다:
- Elif HINDIE, MD
- 이메일: elif.hindie@chu-bordeaux.fr
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Bouches Du Rhône
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Marseille, Bouches Du Rhône, 프랑스
- 아직 모집하지 않음
- Hôpital LaTimone
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연락하다:
- David TAIEB, MD
- 이메일: David.TAIEB@ap-hm.fr
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Age ≥ at 18 years old,
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Patient treated in the Nuclear Medicine Department for the treatment by metabolic radiotherapy,
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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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of patients who gave their consent to participate in the study
기간: 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
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공동 작업자 및 조사자
수사관
수사관
- 연구 의자: Emmanuel DESHAYES, MD, Institut régional du Cancer Montpellier
간행물 및 유용한 링크
일반 간행물
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- 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.
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- 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.
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- 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.
유용한 링크
- <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>
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- PROICM 2019-10 BRI
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .