NCT04104529

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Oct 2019Oct 2026

First Submitted

Initial submission to the registry

September 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 28, 2019

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 5, 2026

Status Verified

November 1, 2025

Enrollment Period

6.9 years

First QC Date

September 24, 2019

Last Update Submit

February 3, 2026

Conditions

Keywords

thyroid cancerprostate cancerneuroendocrine tumorsnuclear medecine

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who gave their consent to participate in the study

    The proportion of patients who consent to participate in the study among the screened patients

    Until the study completion: 5 years

Study Arms (1)

Biological collection

EXPERIMENTAL

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 thyroĂ¯d 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)

Other: Biological collectionOther: tumor collection

Interventions

The biological collection will also include samples of blood samples collected before and during treatment.

Biological collection

Tumor collection (diagnosis) will be done for thyroid cancer and neuroencrine

Biological collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hopital Haut LĂ©vĂªque

Bordeaux, Aquitaine, France

RECRUITING

HĂ´pital LaTimone

Marseille, Bouches Du RhĂ´ne, France

NOT YET RECRUITING

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

RECRUITING

Institut Universitaire du Cancer de Toulouse

Toulouse, 31100, France

RECRUITING

Related Publications (25)

  • 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: 25853132BACKGROUND
  • 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: 26917443BACKGROUND
  • 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: 26729091BACKGROUND
  • 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.

    PMID: 22551127BACKGROUND
  • 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.

    PMID: 31040741BACKGROUND
  • 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; NETTER-1 Trial Investigators. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med. 2017 Jan 12;376(2):125-135. doi: 10.1056/NEJMoa1607427.

    PMID: 28076709BACKGROUND
  • 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.

    PMID: 28609356BACKGROUND
  • 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.

    PMID: 23863050BACKGROUND
  • 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.

    PMID: 20167394BACKGROUND
  • Mitchell AJ, Chan M, Bhatti H, Halton M, Grassi L, Johansen C, Meader N. Prevalence of depression, anxiety, and adjustment disorder in oncological, haematological, and palliative-care settings: a meta-analysis of 94 interview-based studies. Lancet Oncol. 2011 Feb;12(2):160-74. doi: 10.1016/S1470-2045(11)70002-X. Epub 2011 Jan 19.

    PMID: 21251875BACKGROUND
  • Arrieta O, Angulo LP, Nunez-Valencia C, Dorantes-Gallareta Y, Macedo EO, Martinez-Lopez D, Alvarado S, Corona-Cruz JF, Onate-Ocana LF. Association of depression and anxiety on quality of life, treatment adherence, and prognosis in patients with advanced non-small cell lung cancer. Ann Surg Oncol. 2013 Jun;20(6):1941-8. doi: 10.1245/s10434-012-2793-5. Epub 2012 Dec 22.

    PMID: 23263699BACKGROUND
  • 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.

    PMID: 30564021BACKGROUND
  • 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.

    PMID: 31148330BACKGROUND
  • 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.

    PMID: 29878866BACKGROUND
  • Prieto JM, Blanch J, Atala J, Carreras E, Rovira M, Cirera E, Gasto C. Psychiatric morbidity and impact on hospital length of stay among hematologic cancer patients receiving stem-cell transplantation. J Clin Oncol. 2002 Apr 1;20(7):1907-17. doi: 10.1200/JCO.2002.07.101.

    PMID: 11919251BACKGROUND
  • Kim Y, Spillers RL. Quality of life of family caregivers at 2 years after a relative's cancer diagnosis. Psychooncology. 2010 Apr;19(4):431-40. doi: 10.1002/pon.1576.

    PMID: 19399773BACKGROUND
  • Lloyd-Williams M, Dennis M, Taylor F. A prospective study to determine the association between physical symptoms and depression in patients with advanced cancer. Palliat Med. 2004 Sep;18(6):558-63. doi: 10.1191/0269216304pm923oa.

    PMID: 15453627BACKGROUND
  • Satin JR, Linden W, Phillips MJ. Depression as a predictor of disease progression and mortality in cancer patients: a meta-analysis. Cancer. 2009 Nov 15;115(22):5349-61. doi: 10.1002/cncr.24561.

    PMID: 19753617BACKGROUND
  • Pinquart M, Duberstein PR. Depression and cancer mortality: a meta-analysis. Psychol Med. 2010 Nov;40(11):1797-810. doi: 10.1017/S0033291709992285. Epub 2010 Jan 20.

    PMID: 20085667BACKGROUND
  • 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.

    PMID: 30909317BACKGROUND
  • 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.

    PMID: 24798107BACKGROUND
  • 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.

    PMID: 27194911BACKGROUND
  • Dolbeault S, Bredart A, Mignot V, Hardy P, Gauvain-Piquard A, Mandereau L, Asselain B, Medioni J. Screening for psychological distress in two French cancer centers: feasibility and performance of the adapted distress thermometer. Palliat Support Care. 2008 Jun;6(2):107-17. doi: 10.1017/S1478951508000187.

    PMID: 18501045BACKGROUND
  • 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.

    PMID: 27566250BACKGROUND
  • 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.

    PMID: 40015918BACKGROUND

MeSH Terms

Conditions

Thyroid NeoplasmsProstatic NeoplasmsNeuroendocrine Tumors

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve Tissue

Study Officials

  • Emmanuel DESHAYES, MD

    Institut régional du Cancer Montpellier

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 26, 2019

Study Start

October 28, 2019

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 5, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients

Shared Documents
STUDY PROTOCOL

Locations