Can the value of the tumor biomarker CA-125 divided by the value of the tumor biomarker CEA help in the diagnosis of ovarian cancer in women with pelvic cancer?
| ISRCTN | ISRCTN15248104 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15248104 |
- Submission date
- 15/02/2024
- Registration date
- 16/02/2024
- Last edited
- 04/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
Carbohydrate antigen 125 (CA-125) is a serum tumor marker useful in the follow-up and to detect the recurrence or even the presence of residual ovarian cancer when associated with imaging tests. However, its isolated use is limited for early diagnosis or differential diagnosis of ovarian cancer. Some studies suggest that in the presence of above-normal serum CA-125 levels in non-ovarian cancer patients, a serum CA-125/CEA ratio could confirm non-ovarian cancer. This study aims to find out whether their ratio (CA-125/CEA) can help in the differential diagnosis between ovarian cancer and other neoplasms in the lower abdomen and/or metastases.
Who can participate?
Women who have a mass in the lower part of the abdomen, or metastases in the peritoneum (a type of skin that surrounds most of the organs in the abdomen) and/or ascites (accumulation of fluid in the abdomen).
What does the study involve?
The study involves measuring two tumor biomarkers, CA-125 and CEA, and a tumor pathology exam.
What are the possible benefits and risks of participating?
This is a study with minimal risk for the participants, such as the possible breach of patient data confidentiality. Furthermore, this study does not assess oncological outcomes, but diagnoses. However, the researchers have undertaken not to disclose this data and to maintain total confidentiality. This study may not bring any immediate benefit to the research participant, but it may show possible future benefits for other patients.
Where is the study run from?
Barretos Cancer Hospital (Brazil)
When is the study starting and how long is it expected to run for?
October 2015 to September 2018
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Jeferson Rodrigo Zanon, jeferson.zanon@hcancerjales.com.br, jrzanon@hotmail.com
Contact information
Public, Scientific, Principal Investigator
Avenida Francisco Jalles, 3737
Jales
15706-396
Brazil
 ORCID ID |
0000-0003-2074-1829 |
|---|---|
| Phone | +55 (0)17 3624 3900 |
| jeferson.zanon@hcancerjales.com.br |
Study information
| Study design | Diagnostic cross-sectional retrospective study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital, Laboratory, Medical and other records |
| Study type | Diagnostic |
| Scientific title | Can CA-125/CEA ratio be used for the differential diagnosis between ovarian and non-ovarian cancers? A diagnostic cross-sectional retrospective study |
| Study hypothesis | Is CA-125/CEA ratio a diagnostic tool for the differential diagnosis between ovarian cancer and other advanced intra-abdominal neoplasms? |
| Ethics approval(s) |
Approved 15/04/2016, Research Ethics Committee of the Pio XII Foundation - Barretos Cancer Hospital (Rua Antenor Duarte Vilela, 1331, Barretos, 14784-400, Brazil; +55 (0)17 3321 0347; cep@hcancerbarretos.com.br), ref: 54129515.8.0000.5437 |
| Condition | Ovarian cancer, other intra-abdominal neoplasms |
| Intervention | A diagnostic cross-sectional retrospective study is performed in patients with pelvic mass, peritoneal carcinomatosis and/or ascites and initial suspicion of ovarian malignancy. All patients have serum CA-125, CEA and biopsy. CA-125/CEA cutoffs for ovarian/non-ovarian cancer are determined using ROC curves to determine the best sensitivity and specificity. Population adjustment is performed using propensity score matching (PSM). |
| Intervention type | Other |
| Primary outcome measure | Receiver operating characteristic (ROC) curves to determine the cut-off values for CA-125/CEA ratio in the participants, comparing ovarian cancer with non-ovarian cancer, gastrointestinal cancer, and colorectal cancer, followed by a performance characteristic test to determine sensitivity, specificity, positive predictive value, accuracy (all ovarian cancer positive cases divided by the participants), type I error, 1, and 2 (the power of the test), positive predictive value, negative predictive value, accuracy (all ovarian cancer positive cases divided by all participants), type I error, 1 minus type II error (the power of the test), positive and negative likelihood ratios with pathology findings as the gold standard (chi-squared test or Fisher's test). Measured at a single timepoint. |
| Secondary outcome measures | The same as the primary outcome measure but after propensity score matching analysis (PSM) |
| Overall study start date | 02/10/2015 |
| Overall study end date | 23/09/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Female |
| Target number of participants | 340 |
| Total final enrolment | 338 |
| Participant inclusion criteria | Patients with a pelvic mass, peritoneal carcinomatosis and/or ascites |
| Participant exclusion criteria | 1. Previous surgery at another service 2. If the pathology results showed benign lesions 3. If the sample was insufficient for a definitive diagnosis 4. If no biopsy was performed |
| Recruitment start date | 21/04/2016 |
| Recruitment end date | 20/08/2018 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Barretos
14784-400
Brazil
Sponsor information
Hospital/treatment centre
Rua Antenor Duarte Vilela, 1331
Barretos
14784-400
Brazil
| Phone | +55 (0)17 3321 6600, ext: 7086 |
|---|---|
| secretaria.iep@hcancerbarretos.com.br | |
| Website | https://www.hcancerbarretos.com.br/ |
"ROR" |
https://ror.org/00f2kew86 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 10/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Jeferson Rodrigo Zanon (jeferson.zanon@hcancerjales.com.br, jrzanon@hotmail.com). The type of data that will be shared: SPSS data bank. Dates of availability: Indefinitely This study was approved by the local institutional review board (number 54129515.8.0000.5437), and a waiver of informed consent was granted. The database consists of patient information with a personal identifier. This data is stored on the REDCap Platform, which is among the best data collection, management and storage platforms for research and multi-institutional studies. It complies with the American laws on the protection of patient data, the Health Insurance Portability and Accountability Act (HIPAA). In addition to secure data storage and management, research data is stored on the institution's own server. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 14/08/2024 | 04/03/2025 | Yes | No |
Editorial Notes
04/03/2025: Publication reference added.
16/02/2024: Study's existence confirmed by the Pio XII Foundation - Barretos Cancer Hospital.
