Advanced Ovarian Cancer (Stage III or IV) After Neoadjuvant ChemotherapyNCT07678008
Prognostic Value of KELIM Score and Inflammatory Markers in Ovarian Cancer
An observational study of Advanced Ovarian Cancer (Stage III or IV) After Neoadjuvant Chemotherapy and High-grade Serous Ovarian Carcinoma, run by Aya Ahmed Nasser at 1 site in Egypt.
Trial summary
This is a retrospective observational study to evaluate the integrative prognostic value of inflammatory markers, specifically the neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR), alongside the CA-125 Elimination rate constant K (KELIM) score in advanced ovarian cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Ovarian Cancer (Stage III or IV) After Neoadjuvant Chemotherapy, High-grade Serous Ovarian Carcinoma
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of female patients diagnosed with advanced epithelial ovarian cancer (specifically stage III or IV high-grade serous ovarian carcinoma) who were managed and followed up at Sohag University Hospital and Sohag Cancer Center, Egypt. Eligible participants are those who underwent a standard treatment protocol comprising platinum-based neoadjuvant chemotherapy followed by interval cytoreductive surgery between January 2022 and December 2025, and whose medical records contain comprehensive baseline hematological and tumor marker data.
Who may be able to join
- Female patients aged \ge 18 years old., Histologically confirmed advanced epithelial ovarian cancer (High-Grade Serous Ovarian Carcinoma), Stage III or IV.
- Patients who received platinum-based neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS) at Sohag University Hospital or Sohag Cancer Center between 2022 and 2025.
- Available complete medical records, including pre-treatment baseline CBC (for NLR and PLR calculation) and longitudinal CA-125 levels (for KELIM score estimation).
Who cannot join
- Patients with non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord-stromal tumors).
- Patients who underwent primary debulking surgery (PDS) before receiving chemotherapy.
- Patients with concurrent active malignancies or a history of other cancers within the past 5 years.
- Patients with active systemic inflammatory diseases, hematological disorders, or severe infections at baseline that could interfere with baseline inflammatory markers (NLR/PLR).
- Incomplete or missing clinical, surgical, or follow-up data.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrative Prognostic Value of Inflammatory Markers and KELIM Score in Ovarian Cancer Patients Treated With Neoadjuvant Chemotherapy.
This is a retrospective observational study to evaluate the integrative prognostic value of inflammatory markers, specifically the neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR), alongside the CA-125 Elimination rate constant K (KELIM) score in advanced ovarian cancer patients. The study includes patients with advanced serous ovarian cancer (stage III or IV) who received neoadjuvant platinum-based chemotherapy followed by interval debulking surgery at Sohag University Hospital and Sohag Cancer Center between 2022 and 2025. The primary objective is to evaluate how well these biomarkers predict survival outcomes, including progression-free survival (PFS) and overall survival (OS). Additionally, the study aims to assess their significance in predicting the success of complete versus incomplete cytoreductive surgery following neoadjuvant chemotherapy.
- Conditions
- Advanced Ovarian Cancer (Stage III or IV) After Neoadjuvant Chemotherapy, High-grade Serous Ovarian Carcinoma
- Keywords
- KELIM Score, Neutrophil-Lymphocyte Ratio (NLR), Platelet-Lymphocyte Ratio (PLR), Neoadjuvant Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian Cancer Cohort | Advanced serous ovarian cancer patients treated with neoadjuvant chemotherapy followed by interval debulking surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Evaluation of the prognostic value of baseline neutrophil lymphocyte ratio, platelet lymphocyte ratio, and CA 125 KELIM score in predicting progression-free survival in locally advanced ovarian cancer patients receiving platinum-based neoadjuvant chemotherapy followed by interval debulking surgery. PFS is calculated as the time from the date of diagnosis to the date of first documented clinical or radiological disease progression, or death from any cause.
Measured: From the date of diagnosis up to 4 years (assessed using retrospective medical records of patients treated between 2022 and 2025).
Overall Survival (OS)
Evaluation of the prognostic value of baseline neutrophil lymphocyte ratio, platelet lymphocyte ratio, and CA 125 KELIM score in predicting overall survival in locally advanced ovarian cancer patients receiving platinum-based neoadjuvant chemotherapy followed by interval debulking surgery. OS is calculated as the time from the date of diagnosis to the date of death from any cause.
Measured: From the date of diagnosis up to 4 years (assessed using retrospective medical records of patients treated between 2022 and 2025).
Secondary outcomes (1)
Completeness of Interval Cytoreductive Surgery
Evaluation of the significance of baseline neutrophil lymphocyte ratio, platelet lymphocyte ratio, and CA 125 KELIM score in predicting surgical outcomes. The success of the interval debulking surgery will be categorized based on the presence of residual tumor into complete cytoreduction (no macroscopically visible tumor) versus incomplete cytoreduction following neoadjuvant chemotherapy.
Measured: At the time of interval debulking surgery (typically performed after 3 to 6 cycles of neoadjuvant chemotherapy).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jun 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced Ovarian Cancer (Stage III or IV) After Neoadjuvant ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aya Ahmed Nasser
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aya Ahmed Nasser, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678008
- Sponsor's protocol ID
- Soh-Med-26-6-3MS
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data used in this study belong to the medical records of Sohag University Hospital and Sohag Cancer Center and contain sensitive patient clinical information. Due to institutional policies and strict patient confidentiality regulations, individual participant data cannot be made publicly available or shared outside the participating centers.
Publications
Passos VF, Rodrigues LKA, Santiago SL. The effect of magnesium hydroxide-containing dentifrice using an extrinsic and intrinsic erosion cycling model. Arch Oral Biol. 2018 Feb;86:46-50. doi: 10.1016/j.archoralbio.2017.11.006. Epub 2017 Nov 14.
PubMed 29156417Madrigal-Valverde M, Bittencourt RF, Ribeiro Filho AD, Barbosa VF, Vieira CA, Romao EA, Carneiro IB, Azevedo MC, Araujo GR. Quality of domestic cat semen collected by urethral catheterization after the use of different alpha 2-adrenergic agonists. J Feline Med Surg. 2021 Aug;23(8):745-750. doi: 10.1177/1098612X20973183. Epub 2020 Nov 18.
PubMed 33206029
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Prognostic Value of Inflammatory Markers and KELIM Score in Ovarian Cancer Patients Treated With Neoadjuvant Chemotherapy.
- ClinicalTrials.gov ID
- NCT07678008
- Acronym / sponsor ID
- Soh-Med-26-6-3MS
- Conditions
- Advanced Ovarian Cancer (Stage III or IV) After Neoadjuvant Chemotherapy, High-grade Serous Ovarian Carcinoma
- Keywords
- KELIM Score, Neutrophil-Lymphocyte Ratio (NLR), Platelet-Lymphocyte Ratio (PLR), Neoadjuvant Chemotherapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aya Ahmed NasserUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective observational study to evaluate the integrative prognostic value of inflammatory markers, specifically the neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR), alongside the CA-125 Elimination rate constant K (KELIM) score in advanced ovarian cancer patients. The study includes patients with advanced serous ovarian cancer (stage III or IV) who received neoadjuvant platinum-based chemotherapy followed by interval debulking surgery at Sohag University Hospital and Sohag Cancer Center between 2022 and 2025. The primary objective is to evaluate how well these biomarkers predict survival outcomes, including progression-free survival (PFS) and overall survival (OS). Additionally, the study aims to assess their significance in predicting the success of complete versus incomplete cytoreductive surgery following neoadjuvant chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian Cancer Cohort | – | –Advanced serous ovarian cancer patients treated with neoadjuvant chemotherapy followed by interval debulking surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of female patients diagnosed with advanced epithelial ovarian cancer (specifically stage III or IV high-grade serous ovarian carcinoma) who were managed and followed up at Sohag University Hospital and Sohag Cancer Center, Egypt. Eligible participants are those who underwent a standard treatment protocol comprising platinum-based neoadjuvant chemotherapy followed by interval cytoreductive surgery between January 2022 and December 2025, and whose medical records contain comprehensive baseline hematological and tumor marker data.
Key inclusion criteria (3 listed)
- Female patients aged \ge 18 years old., Histologically confirmed advanced epithelial ovarian cancer (High-Grade Serous Ovarian Carcinoma), Stage III or IV.
- Patients who received platinum-based neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS) at Sohag University Hospital or Sohag Cancer Center between 2022 and 2025.
- Available complete medical records, including pre-treatment baseline CBC (for NLR and PLR calculation) and longitudinal CA-125 levels (for KELIM score estimation).
Key exclusion criteria (6 listed)
- Patients with non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord-stromal tumors).
- Patients who underwent primary debulking surgery (PDS) before receiving chemotherapy.
- Patients with concurrent active malignancies or a history of other cancers within the past 5 years.
- Patients with active systemic inflammatory diseases, hematological disorders, or severe infections at baseline that could interfere with baseline inflammatory markers (NLR/PLR).
- Incomplete or missing clinical, surgical, or follow-up data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-Free Survival (PFS)
Time frame: From the date of diagnosis up to 4 years (assessed using retrospective medical records of patients treated between 2022 and 2025).
Evaluation of the prognostic value of baseline neutrophil lymphocyte ratio, platelet lymphocyte ratio, and CA 125 KELIM score in predicting progression-free survival in locally advanced ovarian cancer patients receiving platinum-based neoadjuvant chemotherapy followed by interval debulking surgery. PFS is calculated as the time from the date of diagnosis to the date of first documented clinical or radiological disease progression, or death from any cause.
Overall Survival (OS)
Time frame: From the date of diagnosis up to 4 years (assessed using retrospective medical records of patients treated between 2022 and 2025).
Evaluation of the prognostic value of baseline neutrophil lymphocyte ratio, platelet lymphocyte ratio, and CA 125 KELIM score in predicting overall survival in locally advanced ovarian cancer patients receiving platinum-based neoadjuvant chemotherapy followed by interval debulking surgery. OS is calculated as the time from the date of diagnosis to the date of death from any cause.
1 secondary outcome
Completeness of Interval Cytoreductive Surgery
Time frame: At the time of interval debulking surgery (typically performed after 3 to 6 cycles of neoadjuvant chemotherapy).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 29156417Passos VF, Rodrigues LKA, Santiago SL. The effect of magnesium hydroxide-containing dentifrice using an extrinsic and intrinsic erosion cycling model. Arch Oral Biol. 2018 Feb;86:46-50. doi: 10.1016/j.archoralbio.2017.11.006. Epub 2017 Nov 14.
- Background: PubMed 33206029Madrigal-Valverde M, Bittencourt RF, Ribeiro Filho AD, Barbosa VF, Vieira CA, Romao EA, Carneiro IB, Azevedo MC, Araujo GR. Quality of domestic cat semen collected by urethral catheterization after the use of different alpha 2-adrenergic agonists. J Feline Med Surg. 2021 Aug;23(8):745-750. doi: 10.1177/1098612X20973183. Epub 2020 Nov 18.
- Individual participant dataSharing planned: No. The data used in this study belong to the medical records of Sohag University Hospital and Sohag Cancer Center and contain sensitive patient clinical information. Due to institutional policies and strict patient confidentiality regulations, individual participant data cannot be made publicly available or shared outside the participating centers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Ovarian Cancer (Stage III or IV) After Neoadjuvant Chemotherapy and High-grade Serous Ovarian Carcinoma, run by Aya Ahmed Nasser at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From the date of diagnosis up to 4 years (assessed using retrospective medical records of patients treated between 2022 and 2025).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07678008, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.