| CTRI Number |
CTRI/2023/01/049023 [Registered on: 16/01/2023] Trial Registered Prospectively |
| Last Modified On: |
14/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Blood Tests of Immunological Biomarkers can predict the outcomes of Cytoreductive Surgery (Complete Tumor and Tumor Deposit Removal) and Hyperthermic Intraperitoneal Chemotherapy (Heated Chemotherapy in the abdomen during Surgery), in Ovarian Cancer patients |
|
Scientific Title of Study
|
A prospective study to appraise the role of Immunological Biomarkers to predict the post operative outcomes of Epithelial Ovarian Carcinoma patients undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shouptik Basu |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Surgical Oncology AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
9153041506 |
| Fax |
|
| Email |
shouptik10324@aiimspatna.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Jagit Kumar Pandey |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Surgical Oncology AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
9153041506 |
| Fax |
|
| Email |
drjagjitkp@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Shouptik Basu |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Surgical Oncology AIIMS Patna
BIHAR
801507
India |
| Phone |
9153041506 |
| Fax |
|
| Email |
shouptik10324@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Patna
Aurangabad Rd, Phulwari Sharif, Patna, Bihar 801507 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Dr Shouptik Basu |
All India Institute of Medical Sciences |
Department of Surgical Oncology
All India Institute of Medical Sciences
Phulwarishariff, Aurangabad Road
Patna
BIHAR |
9153041506
shouptik10324@aiimspatna.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Patna |
Approved |
|
|
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 |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Patient’s requiring Upfront Cytoreductive Surgery and Interval
Cytoreduction after Chemotherapy
2. Cytology or Biopsy proven Epithelial Ovarian malignancies
3. Localized Metastasis on Imaging (CECT scans will be the most commonly
used investigation, as per institutional protocol)
4. Good Performance status (KPS-100-40 or ECOG -0-2)
5. Age >18 yrs < 70 years (extremes of age is to be avoided due to
anticipation of the morbidity of the surgery)
6. Preexisting co-morbid conditions that DONOT preclude CRS and HIPEC
7. ASA I to III |
|
| ExclusionCriteria |
| Details |
1. Patient NOT consenting for Cytoreductive Surgery and HIPEC
2. Co morbidities that are a constant threat to the patient’s life
3. Poor performance Status and ASA IV and V
4. Study drop out |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CRS and HIPEC have a definitive role in the management of Epithelial Ovarian Cancers and CRP Kinetics help to predict postoperative morbid events or sub optimal surgery, compared to only WBC (Total Leukocyte) Counts. |
1 week |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Post Operative Complications and Morbid Surgical Events, including 30 and 90 days Morbidity |
90 days |
|
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Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
16/01/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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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
|
With emerging developments in Oncology, Ovarian Carcinoma has been rationalized to be treated with CRS and HIPEC since most of the disease has a significant burden of Peritoneal spread (75%), wherein localized tumour resection and heated chemotherapy aids to vanquish the localized peritoneal disease. AIIMS is an apex institute and tertiary care referral centre catering to people all over India. This study is unique and aims to provide insight into the demographic profile and surgical outcomes in Epithelial Ovarian Cancer patients in India. Like all extensive surgeries CRS and HIPEC require meticulous post-operative care, not only due to the complexity of the surgery but also because the patients undergoing the surgery suffer from a number of comorbidities that may jeopardize the outcomes of the surgery. Early detection of postoperative complications is important to avoid delays in management. However, in patients treated with CRS and HIPEC, the clinical detection of these complications is not always easy, and there are no documented or established clinical or biochemical markers to support the detection of post- operative outcomes, the results re purely subjective on the part of the treating surgeon’s suspicion.
C-reactive protein (CRP) has been reported as a potential tool for predicting postoperative complications. The intensity of the inflammatory event influences the amount of CRP produced.
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