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Sub-type Specific Genomic Mutations in sBOTs

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ClinicalTrials.gov Identifier: NCT03883542
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : October 26, 2021
Sponsor:
Information provided by (Responsible Party):
Stefan Cosyns, Universitair Ziekenhuis Brussel

Brief Summary:

The aim of this study is to identify different origin in carcinogenesis between serous borderline ovarian tumors presenting a. without implants, b. with non-invasive implants, c. with invasive implants and d. with micropapillary pattern.

The presence of specific mutations could suggest for a more aggressive primary treatment if a higher risk of recurrence can be expected.


Condition or disease Intervention/treatment
Ovarian Neoplasm Epithelial Genetic: genomic mutations study

Detailed Description:

Introduction Borderline Ovarian Tumors (BOTs) behave indolently in the vast majority of cases and the prognosis is usually favorable. There is more evidence that two subtypes of BOTs represent a higher risk of recurrence or even progression to an invasive ovarian cancer. In case of a presentation with a micro-papillary grow pattern or when invasive implants are diagnosed the prognosis tend to be less favorable.

Genome sequencing in ovarian cancer helped to differentiate two different pathways in the carcinogenesis.

Low grade serous carcinomas evolving from adenofibromas or borderline tumors over non-invasive micropapillary serous borderline tumors to invasive micropapillary serous carcinoma, show frequent mutations in the Kirsten Rat Sarcoma gene (KRAS), B-Raf Kinase gene(BRAF), Erb-B2 Receptor Tyrosine Kinase 2 gene (ERBB2), Phosphatase and Tensin homolog gene (PTEN), Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA) and Catenin Beta 1 gene (CTNNB1). This pathway is called Type I and is characterized by a slow step-wise process. These low-grade invasive tumors are indolent and are known with a better outcome than high-grade invasive tumors.

In contrast the Type II pathway development of invasive tumors is rapid and vast majority of tumors show a Tumor Protein p53 (TP53) mutation and loss of Breast Cancer type 1 susceptibility protein (BRCA1).

The aim of this study is to identify different origin in carcinogenesis between serous borderline ovarian tumors presenting a. without implants, b. with non-invasive implants, c. with invasive implants and d. with micropapillary pattern.

The presence of specific mutations could suggest for a more aggressive primary treatment if a higher risk of recurrence can be expected.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Sub-type Specific Genomic Mutations in Serous Borderline Ovarian Tumors
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Group/Cohort Intervention/treatment
serous BOT
simple serous BOT ovarian tissue
Genetic: genomic mutations study

Sequencing of the DNA samples extracted from the subgroups

  1. serous BOT tissue,
  2. serous BOT tissue with non-invasive implants and
  3. serous BOT tissue with micropapillary grow pattern will undergo a panel testing for Type 1 genes (small panel 15-40 mutations) AND p53 AND BRCA testing

Sequencing of the DNA samples extracted from the serous BOT tissue with invasive implants will undergo a more comprehensive examination (large panel +- 1000 genes checked)


serous BOT with non-invasive implants
BOT ovarian tissue presenting with non-invasive implants
Genetic: genomic mutations study

Sequencing of the DNA samples extracted from the subgroups

  1. serous BOT tissue,
  2. serous BOT tissue with non-invasive implants and
  3. serous BOT tissue with micropapillary grow pattern will undergo a panel testing for Type 1 genes (small panel 15-40 mutations) AND p53 AND BRCA testing

Sequencing of the DNA samples extracted from the serous BOT tissue with invasive implants will undergo a more comprehensive examination (large panel +- 1000 genes checked)


sBOT with micropapillary grow pattern
BOT ovarian tissue presenting with micropapillary grow pattern
Genetic: genomic mutations study

Sequencing of the DNA samples extracted from the subgroups

  1. serous BOT tissue,
  2. serous BOT tissue with non-invasive implants and
  3. serous BOT tissue with micropapillary grow pattern will undergo a panel testing for Type 1 genes (small panel 15-40 mutations) AND p53 AND BRCA testing

Sequencing of the DNA samples extracted from the serous BOT tissue with invasive implants will undergo a more comprehensive examination (large panel +- 1000 genes checked)


serous BOT with invasive implants
sBOT ovarian tissue presenting with invasive implants at the time of diagnosis
Genetic: genomic mutations study

Sequencing of the DNA samples extracted from the subgroups

  1. serous BOT tissue,
  2. serous BOT tissue with non-invasive implants and
  3. serous BOT tissue with micropapillary grow pattern will undergo a panel testing for Type 1 genes (small panel 15-40 mutations) AND p53 AND BRCA testing

Sequencing of the DNA samples extracted from the serous BOT tissue with invasive implants will undergo a more comprehensive examination (large panel +- 1000 genes checked)





Primary Outcome Measures :
  1. genetic mutations [ Time Frame: 2020 ]
    amount and type of genetic mutations in different subgroups will be analyzed and compared between the different subgroups. Are the mutations suggestive for a type I or type II pathway differentiation?


Biospecimen Retention:   Samples With DNA
Macrodissection of borderline ovarian tumor tissue. DNA extraction from paraffin embedded material for genetic analysis.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with proven serous bordeline ovarian tumors.
Criteria

Inclusion Criteria:

  • Paraffin embedded material from the original borderline ovarian tumor must be present and of good quality for DNA extraction.
  • Original slides are available for central pathological review.

Exclusion Criteria:

  • Presence of invasive ovarian carcinoma.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883542


Contacts
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Contact: Stefan Cosyns, Dr 24776020 ext +32 scosyns@uzbrussel.be

Locations
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Belgium
Universitair Ziekenhuis UZBrussel Recruiting
Jette, Brussels, Belgium, 1090
Contact: Stefan Cosyns, Md    24776020 ext 0032    Scosyns@uzbrussel.be   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: stef cosyns, dr UZBrussel
Publications:
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Responsible Party: Stefan Cosyns, Principal Investigator, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03883542    
Other Study ID Numbers: sBOT
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: October 26, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stefan Cosyns, Universitair Ziekenhuis Brussel:
low malignant potential
serous
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders