Clinico-biological Database in Patients Treated With Metabolic Radiotherapy in the Nuclear Medicine Department

Official title

Establishment of a Clinico-biological Database in Patients Treated With Metabolic Radiotherapy in the Nuclear Medicine Department

Overview

Development of a clinico-biological database allowing the provision of clinical data and corresponding biological materials to the medical and scientific community.

Detailed description

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 emitters less (Iodine-131, Lutecium-177), alpha (Radium-223) or Auger (Indium-111). They will target tumor cells either by natural tropism (iodine for thyroid cancer, for example) or by coupling them to a vector (antibody, peptide ...).

Patients with thyroid cancer, prostate cancer or neuroendocrine tumors 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.

Interventions

• Other Biological collection
  The biological collection will also include samples of blood samples collected before and during treatment.
• Other tumor collection
  Tumor collection (diagnosis) will be done for thyroid cancer and neuroencrine

Primary outcome measures

• Proportion of patients who gave their consent to participate in the study [Time frame: Until the study completion: 5 years]

Eligibility criteria

Inclusion criteria

• Age ≥ at 18 years old,
• 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
• prostate cancer.
• Patient having accepted the complementary blood sample,
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 4 centers

• Hopital Haut Lévêque — Bordeaux
• Hôpital LaTimone — Marseille
• Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle — Montpellier
• Institut Universitaire du Cancer de Toulouse — Toulouse

Publications

• 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. PMID 25853132
• 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. PMID 26917443
• 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. PMID 26729091
• 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. PMID 22551127
• 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. PMID 31040741
• Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, Mittra E, Kunz PL, Kulke MH, Jacene H, Bushnell D, O'Dorisio TM, Baum RP, Kulkarni HR, Caplin M, Lebtahi R, Hobday T, Delpassand E, Van Cutsem E, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Oberg K, Lopera Sierra M, Santoro P, Thevenet T, Erion JL, Ruszniewski P, Kwekkeboom D, Krenning E; NETTE PMID 28076709
• 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. do PMID 28609356
• 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 a PMID 23863050

Identifiers

NCT: NCT04104529 · PROICM 2019-10 BRI

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗