NCT02705144

Brief Summary

To characterize stem cell compartments in their niches in different clinical situations (non-diseased compared to emphysematous and fibrotic pulmonary tissue) and to assess their proliferative and developmental properties in vitro. To further implement lung organoid culture system in the drug screening and development of patient personalized medicine.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

February 21, 2016

Last Update Submit

March 5, 2016

Conditions

Lung Diseases, Interstitial

Outcome Measures

Primary Outcomes (1)

  • The number of stem cell compartments in their niches in different clinical situations (non-diseased compared to emphysematous and fibrotic pulmonary tissue) .

    2 years

Secondary Outcomes (1)

  • The number of organoids in their cellular positions

    2 years

Study Arms (3)

biopsies from lung tissue affected by emphysema

analysis of the number of stem cell niches

Other: analysis of the number of stem cell niches

biopsies from lung tissue affected by interstitial fibrosis

analysis of the number of stem cell niches

Other: analysis of the number of stem cell niches

biopsies from normal appearance lung tissue

analysis of the number of stem cell niches

Other: analysis of the number of stem cell niches

Interventions

analysis of the number of stem cell nichesOTHER

to assess stem cell compartments in their niches and their proliferative and developmental properties in vitro

biopsies from lung tissue affected by emphysemabiopsies from lung tissue affected by interstitial fibrosisbiopsies from normal appearance lung tissue

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with lung emphysema and interstitial lung disease as the background for lung cancer

You may qualify if:

  • lung emphysema, lung interstitial fibrosis, lung cancer patients

You may not qualify if:

  • lung infectious diseases (bronchiectasis, lung abscess, pneumonia)
  • pulmonary edema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Israel

Location

Related Publications (3)

  • Rosen C, Shezen E, Aronovich A, Klionsky YZ, Yaakov Y, Assayag M, Biton IE, Tal O, Shakhar G, Ben-Hur H, Shneider D, Vaknin Z, Sadan O, Evron S, Freud E, Shoseyov D, Wilschanski M, Berkman N, Fibbe WE, Hagin D, Hillel-Karniel C, Krentsis IM, Bachar-Lustig E, Reisner Y. Preconditioning allows engraftment of mouse and human embryonic lung cells, enabling lung repair in mice. Nat Med. 2015 Aug;21(8):869-79. doi: 10.1038/nm.3889. Epub 2015 Jul 13.

    PMID: 26168294BACKGROUND

  • Raghu G, Rochwerg B, Zhang Y, Garcia CA, Azuma A, Behr J, Brozek JL, Collard HR, Cunningham W, Homma S, Johkoh T, Martinez FJ, Myers J, Protzko SL, Richeldi L, Rind D, Selman M, Theodore A, Wells AU, Hoogsteden H, Schunemann HJ; American Thoracic Society; European Respiratory society; Japanese Respiratory Society; Latin American Thoracic Association. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis. An Update of the 2011 Clinical Practice Guideline. Am J Respir Crit Care Med. 2015 Jul 15;192(2):e3-19. doi: 10.1164/rccm.201506-1063ST.

    PMID: 26177183BACKGROUND

  • Sanchez-Salcedo P, Wilson DO, de-Torres JP, Weissfeld JL, Berto J, Campo A, Alcaide AB, Pueyo J, Bastarrika G, Seijo LM, Pajares MJ, Pio R, Montuenga LM, Zulueta JJ. Improving selection criteria for lung cancer screening. The potential role of emphysema. Am J Respir Crit Care Med. 2015 Apr 15;191(8):924-31. doi: 10.1164/rccm.201410-1848OC.

    PMID: 25668622BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Lung tissue biopsies

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Interventional Pulmonology Unit

Study Record Dates

First Submitted

February 21, 2016

First Posted

March 10, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2019

Last Updated

March 10, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)