CTRI Number |
CTRI/2020/11/028987 [Registered on: 09/11/2020] Trial Registered Prospectively |
Last Modified On: |
05/11/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Descriptive study |
Study Design |
Other |
Public Title of Study
|
Clinical characteristics of patients with lung mass in a tertiary hospital in a sub-himalayan region |
Scientific Title of Study
|
Clinico-pathological characteristics of patients with lung mass with emphasis on lung cancer in a tertiary teaching hospital in a sub-himalayan region: a prospective descriptive study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Rahul kumar |
Designation |
Senior Resident |
Affiliation |
AIIMS, Rishikesh |
Address |
Departement Of Surgical oncology, AIIMS Rishikesh Sturida Colony, Rishikesh, Dehradun UTTARANCHAL 249203 India |
Phone |
8800335660 |
Fax |
|
Email |
drraulinsa@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Pankaj Kumar Garg |
Designation |
Additional Professor |
Affiliation |
AIIMS, Rishikesh |
Address |
Departement Of surgical ONcology, AIIMS rishikesh Sturida Colony, Rishikesh, Dehradun UTTARANCHAL 249203 India |
Phone |
8800335660 |
Fax |
|
Email |
dr.pankajgarg@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Rahul kumar |
Designation |
Senior Resident |
Affiliation |
AIIMS, Rishikesh |
Address |
Departement of Surgical Oncology, AIIMS Rishikesh Sturida Colony, Rishikesh, Dehradun UTTARANCHAL 249203 India |
Phone |
8800335660 |
Fax |
|
Email |
drraulinsa@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
AIIMS Rishikesh |
Address |
Rishkesh, Dehradun, UK |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Rahul Kumar |
AIIMS , Rishikesh |
Departement of surgical oncology and Departement of Pulmonology Dehradun UTTARANCHAL |
8800335660
drraulinsa@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
institutional Ethics Committee, AIIMS Rishikesh |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
75.00 Year(s) |
Gender |
Both |
Details |
Patients with radiologically detected single lung mass, or multiple masses in patient not known to have malignancy |
|
ExclusionCriteria |
Details |
Simultaneous presence of a non-pulmonary neoplasm with multiple lung metastasis where biopsy is not contemplated.
History of prior malignancy with short remission.
Any contraindication for the biopsy
Poor performance status (ECOG 3 or more), uncorrectable coagulopathy , Un- cooperative patient, Severe Pulmonary hypertension
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
|
Blinding/Masking
|
|
Primary Outcome
|
Outcome |
TimePoints |
Different histopathological causes of lung masses. |
at baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
Duration of primary and secondary delay in diagnosis of primary lung mass. |
first visit |
Clinico- radiological profile of the neoplastic causes of lung mass |
2 weeks |
4. Histopathological type, immunohistochemical markers and stage of the patients diagnosed with lung cancer |
1 month |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
16/11/2020 |
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
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Lung cancer is the leading cause of cancer-related
morbidity and mortality worldwide and Lung mass is the most common radiologic
presentation of lung (1). An extensive
literature search to look for standard evidence based description of lung mass
and its management protocols highlighted scarcity af literature - lung mass continues
to remain an ill-defined entity. Conventionally, a lung mass is defined as ‘any pleural or pulmonary lesion seen on chest radiograph
as an opacity greater than 3 cm’(2). Pulmonary
nodule is the term used for any rounded or irregular opacity measuring 3 cm or
less in diameter surrounded by normal lung parenchyma (3). Differentail diagnosis of a lung mass includes lung neoplasm, tuberculosis,
nodular Sarcoidosis, lung abscess, focal organizing pneumonia, inflammatory
myofibroblastic tumor and pulmonary liposarcoma. These differentials are
frequently discussed in the literature; however, there is paucity of evidence
to suggest proportional distribution of these etiologies. Subsequently. a
tissue diagnosis is required to confirm the diagnosis and manage the patient
accordingly.
Lung cancer is the
leading cause of cancer-related mortality worldwide including India. However,
mortality rates are higher in india as large number of cases are diagnosed with
advanced stage disease, one of the attributable cause of poor treatment outcome.(4) Delay in diagnosis in patients with lung mass is a
potential cause of progression of disease and delay in treatment. Delay in
diagnosis can occur at various levels, and a number of factors are responsible
for it. Primary delay is defined as time duration between the occurrence of
symptoms and the first contact with the clinician. In other words, whne a
patiet delays seeking medical care in the early stage of disease when symptoms
are mild. Common factors that contribute to primary delay are – (a) lack of
awareness, (b) poverty, (c) unavailablilty
of health care facilities in the vicinity, and (d) widespread presence of
unrqualified medical practitioners. Secondary delay is defined as the period
between the patient contact with the clinician and the definitive diagnosis of
the disease.(5) Causes of secondary delay usually includes –
institution of empirical treatment (usually antituberculsosis treatment) by the
clinicians or unqualified practitioners, scarcity of expertise for tissue
biopsy, and long waiting time at public hospitals.
Tuberculosis
is endemic to Indian subcontinent and is one of the disease which may
masquaerade lung cancer very closely in both clinical and radiological
features. In a developing economy like India, every fifth case of lung cancer is
initially diagnosed as sputum-negative tuberculosis and treated accordingly (6). Empirical anti-tuberculosis
treatment is highly prevalent in India due to high prevalence of pulmonary tuberculosis and is a major
attribute to secondary delay in the diagnosis of lung cancer. Sarcoidosis
masquerading as lung malignancy and vice versa is often reported and can, at
times, be a diagnostic challenge. These factors delay the diagnosis of lung
cancer and results in poor treatment outcomes.
The
study is aimed to analyze the possible causes of lung masses in patients residing in a subhimalayan region
and the reasons for delay in definite diagnosis. An attempt will be made to
generate score based on clinico-pathological characteristics of lng masses to
diagnoses lung cancer. This score can help avoid the delays in the management
of lung cancer. |