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Status unknownNCT02809898Updated Oct 17, 2019

The Role of ctDNA and PBMC in Treatment of Biliary Tract Cancer

An observational study in Biliary Tract Neoplasms, sponsored by RenJi Hospital. Status unknown at 4 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-10-17.

Sponsored by RenJi Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Our study aims to evaluate the role of ct-DNA and PBMC as biomarkers in the treatment of biliary tract cancer.

Read the detailed description

Biliary cancer ranked fifth in all gastrointestinal malignant cancer. Epidemiological surveys showed a significant increasing trend in recent years. How can make an early diagnosis of bile duct cancer as well as prognostic evaluation and efficacy monitoring, has become the hotspot. "liquid biopsy", which is meant to detect cancers by sequencing the DNA in a few drops of a person's blood. It may detect cancers early, even before symptoms arise, when there is just a few cells in the blood circulation.

cf-DNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA. There is evidence that some of the cf-DNA originates from tumoral tissue. This, and the fact that cf-DNA can easily be isolated from the circulation and other body fluids of patients, makes it a promising candidate as a non-invasive biomarker of cancer. And we call the cf-DNA of tumor as ct-DNA.

Peripheral blood mononuclear cells (PBMC) is any peripheral blood cell having a round nucleus. These cells can be extracted from whole blood using ficoll, a hydrophilic polysaccharide. PBMC contains genetic material of tumor and may be applied as a biomarker.

This study aims to evaluate the role of ct-DNA and PBMC as biomarkers in the treatment of biliary tract cancer.

02

Conditions studied

  • Biliary Tract Neoplasms

Keywords

  • Biomarkers, Neoplasms
03

In context

Biliary Tract Neoplasms

492 studies on the registry are indexed under Biliary Tract Neoplasms; 191 are open to participants now.

This study's planned enrollment of 30 is below the median of 160 across 68 observational studies indexed under Biliary Tract Neoplasms.

Browse Biliary Tract Neoplasms studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 550 studies on the registry; 248 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with suspected biliary tract cancer.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with suspected biliary tract cancer
  • Age from 18 - 70 years
  • No serious organic and mental illness;

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • No pathologic result
  • Suffering other malignancies at the same time.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • Proceduresurgery or biopsy

    Do radical surgery or biopsy to obtain a pathological result

06

What researchers measure

Primary outcomes

  1. Pathological diagnosis of gallbladder polyps (Cholesterol / Adenoma / Others)

    Sensitivity and specificity

    Time frame: intraoperative

Secondary outcomes

  1. Tumor status (worse/ maintain/ better)

    the level of ct-DNA compared with the tumor burden

    Time frame: 3 years

07

Study locations

2 of 4 sites recruiting
  • Huadong Hospital
    Shanghai, 200000, China
    Not yet recruiting
  • Shanghai Yangpu district central hospital
    Shanghai, 200000, China
    Recruiting
  • Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
    Shanghai, China
    Recruiting
  • Shanghai Changzheng Hospital
    Shanghai, China
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2016 (actual). Primary completion is estimated for Dec 2020, 53 months after the start.

Of 43 observational studies under Biliary Tract Neoplasms, half reached primary completion within 130 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 132. This study's planned 53 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 20, 2016
First posted
Jun 22, 2016
StartActual
Jul 2016
Primary completionEst.
Dec 2020
CompletionEst.
Dec 2020
Last update
Oct 17, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02809898
Lead sponsor
RenJi Hospital
Collaborators
Huadong Hospital, Shanghai Changzheng Hospital, Yangpu District Central Hospital Affiliated to Tongji University
Responsible party
Sponsor
First posted
Jun 22, 2016
Start date
Jul 2016
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Oct 17, 2019

Study contacts

Tao Chen, M.D.
Contact
dr_chentao78@163.com
+8613601779874
Yunhe Zhang, M.D.
Contact
zyhe31@163.com
+8613917908722
Tao Chen, M.D.
principal investigator · Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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