NCT04577495

Brief Summary

Thymoma is the most common primary tumor of the anterior mediastinum. Complete surgical resection is the mainstay of treatment of these tumors. The staging and histological classification of thymoma is still a matter of discussion. Preoperative computed tomography (CT) scan parameters that correlate with histology, stage and prognosis also still have to be completely assessed. The aim of this study is to evaluate the potential association between clinical, radiologic and pathologic characteristics in patients submitted to surgical treatment for thymoma, assessing their prognostic value. Data of patients submitted to surgical resection for pathologically proven thymoma at our Department of Thoracic Surgery between January 2005 and December 2015 will be retrospectively reviewed. The correlation of preoperative CT scan features, histological and pathological characteristics of thymomas will be evaluated, assessing the prognostic role of these factors.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Status
completed

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 Start

First participant enrolled

January 1, 2005

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

10.9 years

First QC Date

September 25, 2020

Last Update Submit

October 5, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    Disease free survival according to CT scan parameters, stage and histology

    5 years

Eligibility Criteria

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

Patients with thymoma submitted to surgical treatment

You may qualify if:

  • Patients with surgically-treated thymoma

You may not qualify if:

  • Incomplete resection
  • Thymic carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Jamilloux Y, Frih H, Bernard C, Broussolle C, Petiot P, Girard N, Seve P. [Thymoma and autoimmune diseases]. Rev Med Interne. 2018 Jan;39(1):17-26. doi: 10.1016/j.revmed.2017.03.003. Epub 2017 Mar 30. French.

    PMID: 28365191BACKGROUND
  • Imbimbo M, Ottaviano M, Vitali M, Fabbri A, Leuzzi G, Fiore M, Franceschini D, Pasello G, Perrino M, Schiavon M, Pruneri G, Dei Tos AP, Sangalli C, Garassino MC, Berardi R, Alessi A, Calareso G, Petrini I, Scorsetti M, Scotti V, Rosso L, Rea F, Pastorino U, Casali PG, Ramella S, Ricardi U, Abate-Daga L, Torri V, Trama A, Palmieri G, Marino M, Zucali PA; TYME network collaborators. Best practices for the management of thymic epithelial tumors: A position paper by the Italian collaborative group for ThYmic MalignanciEs (TYME). Cancer Treat Rev. 2018 Dec;71:76-87. doi: 10.1016/j.ctrv.2018.10.001. Epub 2018 Oct 5.

    PMID: 30366202BACKGROUND
  • Marx A, Strobel P, Badve SS, Chalabreysse L, Chan JK, Chen G, de Leval L, Detterbeck F, Girard N, Huang J, Kurrer MO, Lauriola L, Marino M, Matsuno Y, Molina TJ, Mukai K, Nicholson AG, Nonaka D, Rieker R, Rosai J, Ruffini E, Travis WD. ITMIG consensus statement on the use of the WHO histological classification of thymoma and thymic carcinoma: refined definitions, histological criteria, and reporting. J Thorac Oncol. 2014 May;9(5):596-611. doi: 10.1097/JTO.0000000000000154.

    PMID: 24722150BACKGROUND
  • Suster S, Moran CA. Problem areas and inconsistencies in the WHO classification of thymoma. Semin Diagn Pathol. 2005 Aug;22(3):188-97. doi: 10.1053/j.semdp.2006.02.004.

    PMID: 16711400BACKGROUND
  • Koga K, Matsuno Y, Noguchi M, Mukai K, Asamura H, Goya T, Shimosato Y. A review of 79 thymomas: modification of staging system and reappraisal of conventional division into invasive and non-invasive thymoma. Pathol Int. 1994 May;44(5):359-67. doi: 10.1111/j.1440-1827.1994.tb02936.x.

    PMID: 8044305BACKGROUND
  • Ozawa Y, Hara M, Shimohira M, Sakurai K, Nakagawa M, Shibamoto Y. Associations between computed tomography features of thymomas and their pathological classification. Acta Radiol. 2016 Nov;57(11):1318-1325. doi: 10.1177/0284185115590288. Epub 2016 Jul 20.

    PMID: 26089525BACKGROUND
  • Han X, Gao W, Chen Y, Du L, Duan J, Yu H, Guo R, Zhang L, Ma G. Relationship Between Computed Tomography Imaging Features and Clinical Characteristics, Masaoka-Koga Stages, and World Health Organization Histological Classifications of Thymoma. Front Oncol. 2019 Oct 11;9:1041. doi: 10.3389/fonc.2019.01041. eCollection 2019.

    PMID: 31681579BACKGROUND
  • Luo T, Zhao H, Zhou X. The clinical features, diagnosis and management of recurrent thymoma. J Cardiothorac Surg. 2016 Aug 31;11(1):140. doi: 10.1186/s13019-016-0533-9.

    PMID: 27580949BACKGROUND
  • Hwang Y, Kang CH, Park S, Lee HJ, Park IK, Kim YT, Lee GD, Kim HR, Choi SH, Kim YH, Kim DK, Park SI, Shin S, Cho JH, Kim HK, Choi YS, Kim J, Zo JI, Shim YM, Lee CY, Lee JG, Kim DJ, Paik HC, Chung KY. Impact of Lymph Node Dissection on Thymic Malignancies: Multi-Institutional Propensity Score Matched Analysis. J Thorac Oncol. 2018 Dec;13(12):1949-1957. doi: 10.1016/j.jtho.2018.08.2026. Epub 2018 Sep 11.

    PMID: 30217490BACKGROUND
  • Tseng YC, Hsieh CC, Huang HY, Huang CS, Hsu WH, Huang BS, Huang MH, Hsu HS. Is thymectomy necessary in nonmyasthenic patients with early thymoma? J Thorac Oncol. 2013 Jul;8(7):952-8. doi: 10.1097/JTO.0b013e31828cb3c2.

    PMID: 23594467BACKGROUND

MeSH Terms

Conditions

Thymoma

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasmsThymus NeoplasmsThoracic NeoplasmsNeoplasms by SiteLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • ANGELO CARRETTA, MD

    IRCCS San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2020

First Posted

October 8, 2020

Study Start

January 1, 2005

Primary Completion

December 1, 2015

Study Completion

March 31, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share