NCT05025514

Brief Summary

The investigators wish to set up a pharmaco-epidemiological cohort within the Hospital Territorial Groups of the Cévennes-Gard Camargue, East-Hérault and Haute-Garonne and West Tarn on a specific population, patients undergoing immunotherapy for cancer, as currently there is no data available under "real life" conditions following anti-COVID vaccination19. The hypothesis is that patients undergoing immunotherapy will not develop more vaccine-related adverse events than those observed in the efficacy and safety validation studies of the BNT162b2 mRNA Covid-19, mRNA-1273 SARS CoV-2, Oxford/AstraZeneca and Ad26COV2.S, JMJ Vaccine or J \& J COVID-19 Vaccine.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

13 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

August 25, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 19, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

2.2 years

First QC Date

August 25, 2021

Last Update Submit

January 17, 2022

Conditions

CancerImmunotherapy

Keywords

CancerCovid-19VaccinationImmunotherapy

Outcome Measures

Primary Outcomes (9)

  • Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    24 hours after the vaccination

  • Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    48 hours after the vaccination

  • Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    8 days after the vaccination

  • Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    24 hours after the following vaccination

  • Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    48 hours after the following vaccination

  • Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    8 days after the following vaccination

  • Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    1 month after the following vaccination

  • Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    3 months after the following vaccination

  • Tolerance of immunotherapy following anti-COVID-19 vaccination

    All local adverse events (pain, rashes, bruising, lymphadenopathy) and systemic adverse events (fever, headaches, fatigue, myalgia, arthralgia, nausea, shivering, diarrhoea, allergic reaction) will be recorded.

    6 months after the following vaccination

Secondary Outcomes (27)

  • A. Tolerance of immunotherapy after anti-COVID-19 vaccination

    24 hours after the vaccination

  • A. Tolerance of immunotherapy after anti-COVID-19 vaccination

    48 hours after the vaccination

  • A. Tolerance of immunotherapy after anti-COVID-19 vaccination

    8 days after the vaccination

  • A. Tolerance of immunotherapy after anti-COVID-19 vaccination

    24 hours after the following vaccination

  • A. Tolerance of immunotherapy after anti-COVID-19 vaccination

    48 hours after the following vaccination

  • +22 more secondary outcomes

Other Outcomes (11)

  • Sex of patients

    Day 0

  • Age of patients

    Day 0

  • Weight of patients

    Day 0

  • +8 more other outcomes

Study Arms (1)

Patients treated for cancer, vaccinated or eligible for anti-COVID vaccination.

Patients undergoing treatment with anti-PD immunotherapy, anti-PDL1 or anti-CTLA4 immunotherapy for any tumour (solid, liquid) treated in the medical oncology departments of the Occitanie area. who have been vaccinated or who are eligible for inoculation with one of the available anti-COVID19 vaccines.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of all patients with cancer requiring anti-PD, anti-PDL1 or antiCTLA4 immunotherapy for any tumour (solid, liquid) who have been vaccinated or eligible for vaccination against COVID19 (of any kind, except live, attenuated virus) and treated in the medical oncology departments of the Occitanie region.

You may qualify if:

  • Patient having been vaccinated or eligible for inoculation with one of the available anti-COVID19 vaccines (except live attenuated virus) while they were or are undergoing immunotherapy with anti-PD1, anti-PDL1 or anti-CTLA4 immunotherapy whatever the tumor (solid, liquid) managed within the medical oncology services of the Occitanie region.
  • Patients affiliated to or beneficiaries of a health insurance scheme.
  • Patients who have received written and oral information about the study and who have no objection to participation.
  • Adult patients (≥ 18 years).

You may not qualify if:

  • Patients who have been vaccinated with a live attenuated vaccine.
  • Minor patients, pregnant women, parturients, nursing mothers, persons in nursing mothers, persons in emergency situations, persons unable to persons unable to express their consent and persons under persons under court protection, subguardianship or subguardianship may not be included in this research.
  • Patients for whom it is impossible to give clear information.
  • Patients who have expressed an objection to participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Clinique Claude Bernard

Albi, 81000, France

RECRUITING

Centre Hospitalier d'Albi

Albi, France

RECRUITING

Centre Hospitalier d'Alès

Alès, 30100, France

RECRUITING

CH d'Auch

Auch, 32008, France

RECRUITING

CH de Bagnols sur Cèze

Bagnols-sur-Cèze, France

RECRUITING

CH de Cahors

Cahors, France

RECRUITING

Clinique des Cèdres - Capio

Cornebarrieu, 31700, France

RECRUITING

Institut de Cancer de Montpellier

Montpellier, 34000, France

RECRUITING

Clinique La Croix du Sud

Quint-Fonsegrives, France

RECRUITING

Centre Hospitalier COMMINGES PYRENEES

Saint-Gaudens, France

NOT YET RECRUITING

Centre Hospitalier du bassin de Thau

Sète, 34200, France

RECRUITING

CH de Bigorre

Tarbes, 65013, France

RECRUITING

Centre Hospitalier de Toulouse

Toulouse, France

RECRUITING

Related Publications (6)

  • Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30.

    PMID: 33378609BACKGROUND

  • Knoll MD, Wonodi C. Oxford-AstraZeneca COVID-19 vaccine efficacy. Lancet. 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. Epub 2020 Dec 8. No abstract available.

    PMID: 33306990BACKGROUND

  • Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Torok ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8.

    PMID: 33306989BACKGROUND

  • Sadoff J, Gray G, Vandebosch A, Cardenas V, Shukarev G, Grinsztejn B, Goepfert PA, Truyers C, Fennema H, Spiessens B, Offergeld K, Scheper G, Taylor KL, Robb ML, Treanor J, Barouch DH, Stoddard J, Ryser MF, Marovich MA, Neuzil KM, Corey L, Cauwenberghs N, Tanner T, Hardt K, Ruiz-Guinazu J, Le Gars M, Schuitemaker H, Van Hoof J, Struyf F, Douoguih M; ENSEMBLE Study Group. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. N Engl J Med. 2021 Jun 10;384(23):2187-2201. doi: 10.1056/NEJMoa2101544. Epub 2021 Apr 21.

    PMID: 33882225BACKGROUND

  • Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.

    PMID: 33301246BACKGROUND

  • Anderson EJ, Rouphael NG, Widge AT, Jackson LA, Roberts PC, Makhene M, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott AB, Flach B, Lin BC, Doria-Rose NA, O'Dell S, Schmidt SD, Corbett KS, Swanson PA 2nd, Padilla M, Neuzil KM, Bennett H, Leav B, Makowski M, Albert J, Cross K, Edara VV, Floyd K, Suthar MS, Martinez DR, Baric R, Buchanan W, Luke CJ, Phadke VK, Rostad CA, Ledgerwood JE, Graham BS, Beigel JH; mRNA-1273 Study Group. Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults. N Engl J Med. 2020 Dec 17;383(25):2427-2438. doi: 10.1056/NEJMoa2028436. Epub 2020 Sep 29.

    PMID: 32991794BACKGROUND

MeSH Terms

Conditions

NeoplasmsCOVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nadine HOUEDE, Professeur

    Centre Hospitalier Universitaire de Nīmes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annissa MEZGARI

CONTACT

+33 4.66.68.34.00drc@CHU-nimes.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2021

First Posted

August 27, 2021

Study Start

October 19, 2021

Primary Completion

January 1, 2024

Study Completion

June 1, 2024

Last Updated

February 1, 2022

Record last verified: 2022-01

Locations

FR(13)