Circulating Tumor CellsNCT02955173
Significance of Circulating Tumor Cells in the Treatment of Gastric and Rectal Cancer
A study testing Surgery in people with Circulating Tumor Cells and Colorectal Cancer, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The primary purpose of this study is to compare both short-term and long-term treatment effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out principles of laparoscopic approach for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Circulating Tumor Cells, Colorectal Cancer, Gastric Cancer
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 467 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to 3 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastric cancer of stage II/III
- Primary rectal carcinoma
- Single lesion
- No metastasis
- Sphincter-saving surgery available
Who cannot join
- History of malignant tumors
- Gastric cancer of stage Ⅳ
- Preoperative neoadjuvant chemotherapy
- History of upper abdominal surgery
- Severe other contradictions of surgery
- Rectal cancer
Show all 10Show fewer
- History of malignant tumors
- Acute bowel obstruction, bleeding or perforation
- Tumor over 6cm in diameter or in severe adhesion with surrounded tissues
- Severe other contradictions of surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Significance of Circulating Tumor Cells (CTC) Detected by the CTCBIOPSY System as Potential Blood-based Biomarkers in Providing Prognostic and Predictive Information for Surgical Treatment of Gastric and Rectal Cancer
The primary purpose of this study is to compare both short-term and long-term treatment effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric and rectal cancer treatment using CTC as a biomarker.
Read the detailed description
Laparoscopic surgery represents a milestone for treatment of gastric and rectal cancer, with advantages of minimal invasion and rapid recovery compared to open approach. However, for progressive gastric and rectal cancer, laparoscopic approach has not been officially promoted by NCCN guideline (2015).
Over the past decade, circulating tumor cells (CTCs), originated from a tumor cell, have been identified as potential blood-based biomarkers capable of providing prognostic and predictive Information.
In the present study, the investigators utilize the CTCBIOPSY® system (YZYBIO Company, Wuhan, China), which has been approved by CFDA (Chinese Food and Drug Administration), to detect CTCs, and try to compare both short-term and long-term treatment effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric and rectal cancer treatment using CTC as a biomarker.
- Conditions
- Circulating Tumor Cells, Colorectal Cancer, Gastric Cancer
- Being tested
- Surgery
- Medical subject headings
- Neoplastic Cells, Circulating, Colorectal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Laparoscopic or open surgery for resection of gastric or rectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Open surgery of rectal cancer | Experimental | Patients undergoing rectal cancer resection in an open approach Receives: Procedure: Surgery |
| Laparoscopic surgery of rectal cancer | Experimental | Patients undergoing rectal cancer resection in a laparoscopic approach Receives: Procedure: Surgery |
| Open surgery of gastric cancer | Experimental | Patients undergoing gastric cancer resection in an open approach Receives: Procedure: Surgery |
| Laparoscopic surgery of gastric cancer | Experimental | Patients undergoing gastric cancer resection in a laparoscopic approach Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: Two years
Secondary outcomes (1)
Circulating tumor cell (CTC) test
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startDec 2016
- Primary completion14 Dec 2020
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Circulating Tumor CellsStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital
- Responsible party
- Principal investigator, Sanyuan Hu, Qilu Hospital of Shandong University
- Investigators
- Sanyuan Hu, M.D. Ph.D., Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955173
- Sponsor's protocol ID
- 2016YFC0106003
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 2016
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Benson AB 3rd, Venook AP, Bekaii-Saab T, Chan E, Chen YJ, Cooper HS, Engstrom PF, Enzinger PC, Fenton MJ, Fuchs CS, Grem JL, Grothey A, Hochster HS, Hunt S, Kamel A, Kirilcuk N, Leong LA, Lin E, Messersmith WA, Mulcahy MF, Murphy JD, Nurkin S, Rohren E, Ryan DP, Saltz L, Sharma S, Shibata D, Skibber JM, Sofocleous CT, Stoffel EM, Stotsky-Himelfarb E, Willett CG, Gregory KM, Freedman-Cass D. Rectal Cancer, Version 2.2015. J Natl Compr Canc Netw. 2015 Jun;13(6):719-28; quiz 728. doi: 10.6004/jnccn.2015.0087.
PubMed 26085388Lowes LE, Bratman SV, Dittamore R, Done S, Kelley SO, Mai S, Morin RD, Wyatt AW, Allan AL. Circulating Tumor Cells (CTC) and Cell-Free DNA (cfDNA) Workshop 2016: Scientific Opportunities and Logistics for Cancer Clinical Trial Incorporation. Int J Mol Sci. 2016 Sep 8;17(9):1505. doi: 10.3390/ijms17091505.
PubMed 27618023
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of Circulating Tumor Cells (CTC) Detected by the CTCBIOPSY System as Potential Blood-based Biomarkers in Providing Prognostic and Predictive Information for Surgical Treatment of Gastric and Rectal Cancer
- ClinicalTrials.gov ID
- NCT02955173
- Acronym / sponsor ID
- 2016YFC0106003
- Conditions
- Circulating Tumor Cells, Colorectal Cancer, Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Peking University People's Hospital
- Study start
- Dec 2016
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to compare both short-term and long-term treatment effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric and rectal cancer treatment using CTC as a biomarker.
Detailed description
Laparoscopic surgery represents a milestone for treatment of gastric and rectal cancer, with advantages of minimal invasion and rapid recovery compared to open approach. However, for progressive gastric and rectal cancer, laparoscopic approach has not been officially promoted by NCCN guideline (2015).
Over the past decade, circulating tumor cells (CTCs), originated from a tumor cell, have been identified as potential blood-based biomarkers capable of providing prognostic and predictive Information.
In the present study, the investigators utilize the CTCBIOPSY® system (YZYBIO Company, Wuhan, China), which has been approved by CFDA (Chinese Food and Drug Administration), to detect CTCs, and try to compare both short-term and long-term treatment effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric and rectal cancer treatment using CTC as a biomarker.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Open surgery of rectal cancer | Experimental | Procedure: SurgeryPatients undergoing rectal cancer resection in an open approach |
| Laparoscopic surgery of rectal cancer | Experimental | Procedure: SurgeryPatients undergoing rectal cancer resection in a laparoscopic approach |
| Open surgery of gastric cancer | Experimental | Procedure: SurgeryPatients undergoing gastric cancer resection in an open approach |
| Laparoscopic surgery of gastric cancer | Experimental | Procedure: SurgeryPatients undergoing gastric cancer resection in a laparoscopic approach |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Gastric cancer of stage II/III
- Primary rectal carcinoma
- Single lesion
- No metastasis
- Sphincter-saving surgery available
Key exclusion criteria (10 listed)
- History of malignant tumors
- Gastric cancer of stage Ⅳ
- Preoperative neoadjuvant chemotherapy
- History of upper abdominal surgery
- Severe other contradictions of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryLaparoscopic or open surgery for resection of gastric or rectal cancer | Procedure or surgery | Laparoscopic surgery of gastric cancer, Laparoscopic surgery of rectal cancer, Open surgery of gastric cancer, Open surgery of rectal cancer |
Primary outcome
Disease-free survival
Time frame: Two years
1 secondary outcome
Circulating tumor cell (CTC) test
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Background: PubMed 26085388Benson AB 3rd, Venook AP, Bekaii-Saab T, Chan E, Chen YJ, Cooper HS, Engstrom PF, Enzinger PC, Fenton MJ, Fuchs CS, Grem JL, Grothey A, Hochster HS, Hunt S, Kamel A, Kirilcuk N, Leong LA, Lin E, Messersmith WA, Mulcahy MF, Murphy JD, Nurkin S, Rohren E, Ryan DP, Saltz L, Sharma S, Shibata D, Skibber JM, Sofocleous CT, Stoffel EM, Stotsky-Himelfarb E, Willett CG, Gregory KM, Freedman-Cass D. Rectal Cancer, Version 2.2015. J Natl Compr Canc Netw. 2015 Jun;13(6):719-28; quiz 728. doi: 10.6004/jnccn.2015.0087.
- Background: PubMed 27618023Lowes LE, Bratman SV, Dittamore R, Done S, Kelley SO, Mai S, Morin RD, Wyatt AW, Allan AL. Circulating Tumor Cells (CTC) and Cell-Free DNA (cfDNA) Workshop 2016: Scientific Opportunities and Logistics for Cancer Clinical Trial Incorporation. Int J Mol Sci. 2016 Sep 8;17(9):1505. doi: 10.3390/ijms17091505.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanyuan Hu, M.D. Ph.D. principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery in people with Circulating Tumor Cells and Colorectal Cancer, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02955173, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.