Clinical characteristics of patients with lung mass in a tertiary hospital in a sub-himalayan region

Not yet recruiting

Conditions: Other specified symptoms and signsinvolving the circulatory and respiratory systems,

Registration Number: CTRI/2020/11/028987

Lead Sponsor: AIIMS Rishikesh

Brief Summary: Lung cancer is the leading cause of cancer-relatedmorbidity and mortality worldwide and Lung mass is the most common radiologicpresentation of lung (1). An extensiveliterature search to look for standard evidence based description of lung massand its management protocols highlighted scarcity af literature - lung mass continuesto remain an ill-defined entity. Conventionally, a lung mass is defined as â€˜any pleural or pulmonary lesion seen on chest radiographas an opacity greater than 3 cmâ€™(2). Pulmonarynodule is the term used for any rounded or irregular opacity measuring 3 cm orless 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, inflammatorymyofibroblastic tumor and pulmonary liposarcoma. These differentials arefrequently discussed in the literature; however, there is paucity of evidenceto suggest proportional distribution of these etiologies. Subsequently. atissue diagnosis is required to confirm the diagnosis and manage the patientaccordingly.

Lung cancer is theleading cause of cancer-related mortality worldwide including India. However,mortality rates are higher in india as large number of cases are diagnosed withadvanced stage disease, one of the attributable cause of poor treatment outcome.(4) Delay in diagnosis in patients with lung mass is apotential cause of progression of disease and delay in treatment. Delay indiagnosis can occur at various levels, and a number of factors are responsiblefor it. Primary delay is defined as time duration between the occurrence ofsymptoms and the first contact with the clinician. In other words, whne apatiet delays seeking medical care in the early stage of disease when symptomsare mild. Common factors that contribute to primary delay are â€“ (a) lack ofawareness, (b) poverty, (c) unavailabliltyof health care facilities in the vicinity, and (d) widespread presence ofunrqualified medical practitioners. Secondary delay is defined as the periodbetween the patient contact with the clinician and the definitive diagnosis ofthe disease.(5) Causes of secondary delay usually includes â€“institution of empirical treatment (usually antituberculsosis treatment) by theclinicians or unqualified practitioners, scarcity of expertise for tissuebiopsy, and long waiting time at public hospitals.

Tuberculosisis endemic to Indian subcontinent and is one of the disease which maymasquaerade lung cancer very closely in both clinical and radiologicalfeatures. In a developing economy like India, every fifth case of lung cancer isinitially diagnosed as sputum-negative tuberculosis and treated accordingly (6). Empirical anti-tuberculosistreatment is highly prevalent in India due to high prevalence of pulmonary tuberculosis and is a majorattribute to secondary delay in the diagnosis of lung cancer. Sarcoidosismasquerading as lung malignancy and vice versa is often reported and can, attimes, be a diagnostic challenge. These factors delay the diagnosis of lungcancer and results in poor treatment outcomes.

Thestudy is aimed to analyze the possible causes of lung masses in patients residing in a subhimalayan regionand the reasons for delay in definite diagnosis. An attempt will be made togenerate score based on clinico-pathological characteristics of lng masses todiagnoses lung cancer. This score can help avoid the delays in the managementof lung cancer.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Patients with radiologically detected single lung mass, or multiple masses in patient not known to have malignancy.

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Different histopathological causes of lung masses.	at baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): AIIMS , Rishikesh
🇮🇳
Dehradun, UTTARANCHAL, India
AIIMS , Rishikesh
🇮🇳Dehradun, UTTARANCHAL, India
Dr Rahul Kumar
Principal investigator
8800335660
drraulinsa@gmail.com