| CTRI Number |
CTRI/2024/09/073568 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Validity of KELIM score as a predictor of treatment outcome in patients diagnosed with advanced high grade serous ovarian cancer undergoing neoadjuvant chemotherapy and interval debulking surgery
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Scientific Title of Study
|
Validity of KELIM score as a predictor of treatment outcome in patients diagnosed with advanced high grade serous ovarian cancer undergoing neoadjuvant chemotherapy and interval debulking surgery
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anik Ghosh |
| Designation |
Consultant |
| Affiliation |
Tata Medical center, Kolkata |
| Address |
Tata Medical center
14, MAR (EW), New Town, Rajarhat,
Kolkata 700160
Kolkata WEST BENGAL 700160 India |
| Phone |
|
| Fax |
|
| Email |
anik.ghosh@tmckolkata.com |
|
Details of Contact Person Scientific Query
|
| Name |
Deepti S B |
| Designation |
DrNB Resident |
| Affiliation |
Tata Medical center , Kolkata |
| Address |
Tata Medical center
14, MAR (EW), New Town, Rajarhat,
Kolkata 700160
Kolkata WEST BENGAL 700160 India |
| Phone |
919611145292 |
| Fax |
|
| Email |
deepti.sb@tmckolkata.com |
|
Details of Contact Person Public Query
|
| Name |
Deepti S B |
| Designation |
DrNB Resident |
| Affiliation |
Tata Medical center , Kolkata |
| Address |
Tata Medical center
14, MAR (EW), New Town, Rajarhat,
Kolkata 700160
Kolkata WEST BENGAL 700160 India |
| Phone |
919611145292 |
| Fax |
|
| Email |
deepti.sb@tmckolkata.com |
|
|
Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [not applicable ] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Deepti S B |
Tata Medical Center |
Tata Medical Center
14, MAR (EW), New Town, Rajarhat,
Kolkata 700160
Kolkata WEST BENGAL |
919611145292
deepti.sb@tmckolkata.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata medical center - Institutional Review Board |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
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Intervention / Comparator Agent
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Female |
| Details |
Histological Diagnosis: High Grade Serous Carcinoma (Ovary/Fallopian Tube/Peritoneum, HGSOC)
FIGO Stage(2014): Stage III and Stage IV (including sub-stages)
Will undergo the complete treatment regimen of neoadjuvant chemotherapy followed by interval debulking surgery and completion of remaining chemotherapy at TMCK
|
|
| ExclusionCriteria |
| Details |
- Histological subtype other than HGSOC
- Recurrent HGSOC
- Unable to receive the complete treatment regimen due to any reason
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
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Blinding/Masking
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Primary Outcome
|
| Outcome |
TimePoints |
| To calculate the correlation of KELIM score with histopathological chemotherapy response score (CRS), the surrogate marker of treatment outcome |
16 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To calculate the correlation of KELIM score with
- Surgical complexity score (SCS),
- Completeness of cytoreduction score (CC) and
- Progression free survival (PFS).
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="112" Sample Size from India="112"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This research is proposed to prospectively assess if KELIM score can accurately predict treatment outcomes, in patients with advanced HGSOC receiving NACT. All newly diagnosed patients with HGSOC and FIGO Stage III or IV deemed to be inappropriate for primary debulking surgery by the multidisciplinary team and fit to receive NACT will be recruited into the study. Serum CA-125 levels will be measured and recorded at various time points: a. at the time of diagnosis, b. before every NACT cycle, c. prior to IDS and d. during every follow up visit after treatment completion. In addition, various other parameters related to the study, including intra-operative details and post-operative histological details(eg: Chemotherapy Response Score(CRS) will be recorded. KELIM score will be calculated for these patients using the first three serum CA-125 values during the first 100 days from the start of neoadjuvant chemotherapy, using a mathematical algorithm available on the website: https://www.biomarker-kinetics.org/CA- 125-neo. Patients will be grouped into two groups as per their KELIM Score(< 1 or ≥ 1) and the score will then be correlated with various parameters which are related to treatment outcome. After surgery, patients will complete the remaining chemotherapy and CA-125 will be recorded during follow up visits. Maintenance chemotherapy with targeted agents or PARP inhibitor drugs will be based on the treating team. Standard-of-care protocol for patient follow up will be followed. Rise of serum CA-125 levels above 35U/mL, and/or new onset symptoms suggestive of disease recurrence will initiate imaging with contrast enhanced CT/MRI of the abdomen and/or CT thorax. Radiological confirmation of disease recurrence will be considered as indication of restarting treatment for recurrence.
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