Colorectal Cancer and MelanomaNCT02907086
Circulating Tumor Material in Colorectal Cancer and Melanoma
An observational study of Colorectal Cancer and Melanoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Observational study to allow the collection of blood and medical information to evaluate the role of circulating tumor material in patients with colorectal cancer and melanoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer and Melanoma
- What is being tested?
- blood collection
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2017to 1 Jul 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: colorectal cancer and melanoma patients
Who may be able to join
- The subject must be a patient at the Hospital of the University of Pennsylvania
- Patients with presumed stage II, III, or IV colorectal cancer with planned surgical resection of either the primary tumor or metastatic lesion(s) being evaluated at the Hospital of the University of Pennsylvania
- Patients with histologically confirmed melanoma stage IIb, IIc, IIIa, IIIb, or IIIc/IV scheduled for surgical resection being evaluated at the Hospital of the University of Pennsylvania.
- The subject must be able to provide informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf.
- The subject must be 18 years of age or older.
Who cannot join
- The subject is not able to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Protocol to Permit the Acquisition of Circulating Tumor Material in Colorectal Cancer and Melanoma
Observational study to allow the collection of blood and medical information to evaluate the role of circulating tumor material in patients with colorectal cancer and melanoma
- Conditions
- Colorectal Cancer and Melanoma
- Being tested
- blood collection
- Medical subject headings
- Colorectal Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood collectionOther
Patients will receive a research draw for circulating tumor material analysis with standard clinical labs
| Study group | Role | What they receive |
|---|---|---|
| colorectal cancer | Not described Receives: Other: blood collection | |
| melanoma | Not described Receives: Other: blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of blood samples collected
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start7 Jul 2017
- Primary completion1 Jul 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer and MelanomaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark O'Hara, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907086
- Sponsor's protocol ID
- UPCC 12916
- Status last verified
- Jun 2022
- First submitted
- 13 Sep 2016
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol to Permit the Acquisition of Circulating Tumor Material in Colorectal Cancer and Melanoma
- ClinicalTrials.gov ID
- NCT02907086
- Acronym / sponsor ID
- UPCC 12916
- Conditions
- Colorectal Cancer and Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 20 Sep 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.
Observational study to allow the collection of blood and medical information to evaluate the role of circulating tumor material in patients with colorectal cancer and melanoma
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colorectal cancer | – | Other: blood collection |
| melanoma | – | Other: blood collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- colorectal cancer and melanoma patients
Key inclusion criteria (5 listed)
- The subject must be a patient at the Hospital of the University of Pennsylvania
- The subject must be able to provide informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf.
- The subject must be 18 years of age or older.
Key exclusion criteria (1 listed)
- The subject is not able to provide informed consent.
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 |
|---|---|---|
| blood collectionPatients will receive a research draw for circulating tumor material analysis with standard clinical labs | Other | colorectal cancer, melanoma |
Primary outcome
Number of blood samples collected
Time frame: 24 months
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 6 Jun 2022.
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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.
Mark O'Hara, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Melanoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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 1 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 6 Jun 2022. 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 United States. 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?
Number of blood samples collected (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2022.