| CTRI Number |
CTRI/2025/01/079414 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Survival Outcomes in Advanced Solid Cancer Patients with Low Serum Creatinine Referred for Palliative Care: A Prospective Observational Study. |
|
Scientific Title of Study
|
Survival Analysis in Patients with Advanced Solid Cancers with Low Serum Creatinine Referred to Specialist Palliative Care for Best Supportive Care at a Tertiary Cancer Hospital A Prospective Observational Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raghu Thota |
| Designation |
Professor and Consultant - Palliative Medicine department |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Palliative Medicine, Room no. 75, Main Building, Tata
Memorial Hospital, Dr. E.
Borges road, Parel, Mumbai.
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769077764 |
| Fax |
|
| Email |
ragstho24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghu Thota |
| Designation |
Professor and Consultant - Palliative Medicine department |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Palliative Medicine, Room no. 75, Main Building, Tata
Memorial Hospital, Dr. E.
Borges road, Parel, Mumbai.
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769077764 |
| Fax |
|
| Email |
ragstho24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghu Thota |
| Designation |
Professor and Consultant - Palliative Medicine department |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Palliative Medicine, Room no. 75, Main Building, Tata
Memorial Hospital, Dr. E.
Borges road, Parel, Mumbai.
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769077764 |
| Fax |
|
| Email |
ragstho24@gmail.com |
|
|
Source of Monetary or Material Support
|
| TATA MEMORIAL HOSPITAL
Dr. E Borges Road, Parel, Mumbai - 400 012, Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Borges Marg, Parel, Mumbai,Maharashtra- 400012,India. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prasun P |
Advanced Centre for Treatment, Research and Education in Cancer |
Room no.14 Shanti Sadan building Tata Memorial Centre Advanced Centre for Treatment Research and Education in Cancer, Sector 22, Utsav Chowk CISF road, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh
MAHARASHTRA |
9870450187
drprasunprem@gmail.com |
| Dr Raghu Thota |
Tata Memorial Hospital |
Room no. 75 Department of Palliative Medicine, Ground Floor, Main Building, Tata Memorial Hospital, Dr E Borges road, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9769077764
ragstho24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. 18 years of age or older
2. Diagnosed case of advanced solid cancers havingserum creatinine less than 0.6mg/dLand serum albumin reportswithin last 4 weeks of the visit.
3. Not planned for any disease-directed treatment.
4. Able to sign informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Not willing to participate in the study
2. Pregnant or breastfeeding patients.
3. Children under the age of 18 years.
4. Hematological malignancies.
5. Patients with recent laboratory values not available. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome of this study is Overall survival (OS) defined as the time period between the date of recruitment to the date of death from any cause. To assess the impact of serum creatinine levels (less than 0.6mg/dL) on the frequency of disease progression in cancer patients not on any disease-directed treatment. |
These patients will be followed up every 4 weeks till death or 12 months after recruitment of the last patient via details on the electronic medical record if the patient is visiting the hospital or telephonically to enquire about the general condition of the patient if no details are available on the electronic medical record. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcome of this study is to assess impact on overall survival and median survival of patients not on any disease-directed treatment with serum creatinine of 0.4-0.6mg/dL.
|
These patients will be followed up every 4 weeks till death or 12 months after recruitment of the last patient. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
03/02/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective observational investigation focused on evaluating overall survival (OS) in patients with advanced solid cancers and low serum creatinine (S.Cr) levels who are referred for palliative care. Conducted at Tata Memorial Hospital and Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) the study aims to analyze survival trends and their correlation with low S.Cr levels in the absence of cancer-directed treatments. Key Points: - Aim: To determine survival outcomes in advanced cancer patients with low S.Cr levels (<0.6 mg/dL).
- Primary Outcome: OS, defined as the time from recruitment to death due to any cause. Patients will be followed until death or one year from the recruitment of the last patient.
- Secondary Outcomes: Median survival and the effect of serum albumin levels on survival.
- Sample Size: 120 patients, with a 20% attrition rate considered.
- Methodology: Patients are categorized into two groups based on S.Cr levels (<0.4 mg/dL and 0.4-0.6 mg/dL). Follow-ups are conducted every four weeks via medical records or telephone.
- Statistical Analysis: Kaplan-Meier for survival analysis, and Cox proportional hazards for multivariate analysis.
- Significance: The study findings will enhance prognostic capabilities and inform palliative care decisions.
No invasive procedures are involved, ensuring minimal risks, while all participants receive standard palliative care. |