NCT05011539

Brief Summary

Ovarian cancer is the third most common after endometrial and cervical cancer in societies with a high standard of living; It is the second most common type of gynecological cancer after cervical cancer in societies with a low standard of living, and it is also the deadliest among gynecological cancers. Dynamic thiol-disulfide homeostasis is an antioxidant system that minimizes oxidative damage and prevents cell damage. In the presence of oxidative stress, the thiol groups combine to form the disulfide structure, and when the oxidative stress condition is over, they are separated into thiol groups again. This homeostasis is impaired in conditions that cause oxidative processes such as diabetes, cardiovascular diseases, cancers, rheumatoid arthritis, and chronic kidney failure. This can be determined by measuring the total thiol and native thiol levels. Likewise, the level of ischemia modified albumin increases in the case of oxidative stress. There are studies on this homeostasis in the literature on many types of cancer; There are studies on endometrial cancer and cervical cancer, which are gynecological cancers In this study, the usability of these tests together with other diagnostic tests in the diagnosis of ovarian cancer will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

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

April 9, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

August 15, 2021

Last Update Submit

October 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • thiol - disulfide levels

    the rate of total thiol, native thiol and total oxidant/antioxidant capacity

    April 2021 - January 2022

Study Arms (2)

Ovarian cancer

The patients with ovarian cancer

Control group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Ovarian cancer patients who applied to Izmir Tepecik Training and Research Hospital

You may qualify if:

  • Histopathological diagnosis of ovarian cancer

You may not qualify if:

  • Having an acute or chronic disease that will cause oxidative stress
  • Using alcohol/cigarettes/drugs
  • Using antioxidant agents (such as vitamins A, C, E)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Tepecik Training and Research Hospital

Izmir, Konak, 35020, Turkey (Türkiye)

Location

Related Publications (1)

  • Sezgin B, Kinci MF, Pirincci F, Camuzcuoglu A, Erel O, Neselioglu S, Camuzcuoglu H. Thiol-disulfide status of patients with cervical cancer. J Obstet Gynaecol Res. 2020 Nov;46(11):2423-2429. doi: 10.1111/jog.14480. Epub 2020 Sep 9.

    PMID: 32909381BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 15, 2021

First Posted

August 18, 2021

Study Start

April 9, 2021

Primary Completion

April 1, 2022

Study Completion

May 1, 2022

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations