Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Uterine Cervical Neoplasms

Recurrence

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Participants will have a cervical swab, and plasma HPV at baseline. In addition, a plasma HPV test drawn after completion of radiation. 3 months post chemoradiation, patients will have a PET-CT and plasma HPV completed. Plasma HPV will be drawn at progression/recurrence, if applicable.

Cervical Swab at baseline.

HPV testing at recurrence, if applicable.

Cervical swab

PET-CT will be completed 3 month post chemoradiation.

PET-CT

Plasma HPV will be drawn at baseline, post radiation, 3 month post chemoradiation and at progression (if necessary).

Plasma HPV

Eric Leung, MD

The addition of concurrent chemotherapy to definitive radiation has improved the 5-year survival of women with locally advanced cervical cancer to 58%. To determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy of metabolic response on FDG-PET at 3 months post completion of radical chemo-radiation in patients with locally advanced cervical cancer. Post therapy FDG-PET can help predict progression free survival and overall survival. In addition plasma HPV can be used to monitor response and detect early recurrence. Prospective study will recruit 20 patients with locally advanced cervical cancer to determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy response on post-therapy FDG-PET scan at 3 months.

The addition of concurrent chemotherapy to definitive radiation has improved the 5-year survival of women with locally advanced cervical cancer to 58%, there is much room for improvement. Post-therapy FDG-PET at 3 months can help predict progression-free and overall survival. Tumors continually shed their DNA into the circulation, where it can be accessed to measure disease burden. Cervical cancer is caused by Human Papilloma Virus (HPV); plasma HPV DNA could be used to monitor response and detect recurrence early. While plasma HPV DNA has been shown to correlate with prognosis and predict recurrence in other cancers, there is limited data in locally advanced cervical cancer.

This prospective multi-institutional study will recruit 20 patients with locally advanced cervical cancer to determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy response on post-therapy FDG-PET scan at 3 months. Patients will undergo phlebotomy at the following time-points for the measurement of circulating HPV DNA levels: a) baseline; b) end of radiotherapy;c) 3 months post completion of chemoradiation, along with 3-month FDG-PET and d) at recurrence. This study will provide preliminary estimates of the correlation between plasma HPV DNA level, PET finding and clinical outcome, and inform sample size calculation for a larger study. If proven useful in the future, plasma HPV DNA could enable the identification of patients at high risk of recurrence and individualized treatment.

FDG-PET and Circulating HPV in Patients With Cervical Cancer

FDG-PET and Circulating HPV in Patients With Cervical Cancer Treated With Definitive Chemoradiation

To determine if HPV DNA predates clinical recurrence and/or improves the accuracy of metabolic response on FDG-PET scan at 3 months post completion of radical chemoradiation in patients with locally advanced cervical cancer

Princess Margaret Hospital, Canada

Sunnybrook Health Sciences Centre

Radiation Oncologist

Digestive System Diseases

Rare Diseases

Anus Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

The national follow-up program + collection of blood samples for retrospective translational research

The national follow-up program + ctDNA guided additional imaging + collection of blood samples for retrospective translational research

Patients with HPV negative disease will be included in an observational arm (ARM O)

ARM O: The national follow-up program + collection of blood samples for retrospective translational research

Blood samples in follow-up positive for ctDNA leads to an extra PET-CT scan to detect early treatment failure

AMR B: HPV positive ctDNA guided imaging in follow-up

Karen-Lise G Spindler, Professor

Louise V Laursen, Secretary

Eva Serup-Hansen

Birgitte M. Havelund

Karen-Lise G Spindler

Pia Österlund

Annika Ålgars

Janne B Kjersem

Marianne G Guren

Magnar Johansen

Eva Hofsli

Mia Johansson

Anders Johnsson

Carl Henrik Shah

Calin Radu

Birgitta Lindh

This study investigates if circulating tumor DNA can improve the detection of early treatment failure or recurrence in localized squamous cell carcinoma of the anus (SCCA) after curative chemoradiotherapy thereby increasing the potential for cure. This will be done by comparing the standard follow-up program with ctDNA guided imaging follow-up. Secondly, the aim is to establish early interventions against late morbidities.

Squamous cell carcinoma of the anus (SCCA) is a rare disease with less than 200 new cases in Denmark and Sweden each year and approximately 100 new cases in Norway and Finland but with increasing incidence. Primary treatment is chemo-radiotherapy (CRT) comprising high dose IMRT based radiation therapy with combination chemotherapy of 5-FU and Cisplatin. Overall treatment response is good in small tumors, but less pronounced for high-risk tumors.

In absence of complete pathological response after CRT or local recurrence, patients are evaluated for. salvage surgery. The importance of R0 resection on overall survival has been described in several studies. It is suggested that early detection of treatment failure and recurrences increases the chance of possible curative surgery (R0-resection) and thereby overall survival.

A follow-up program has 3 purposes

1. To detect lack of complete response to primary treatment
2. Early detection of local or distant recurrences
3. Describing and managing late morbidity

Purpose:

The main purpose of this follow-up study is to investigate if circulating tumor tDNA can improve detection of early treatment failure or recurrences thereby assisting in increasing the potential for cure. Secondly, to provide evidence for use of imaging and third objective is to establish early intervention against late morbidities.

NOAC9 - Circulating Tumor DNA Guided Follow-Up in Anal Cancer

NOAC9 - A Phase II Randomised Nordic Anal Cancer Group Study on Circulating Tumor DNA Guided Follow-Up

Disease free survival 2 years from end of therapy

Lead time between ctDNA detected and CT verified recurrences

Pattern of failure defined as ln-field failures (within GTV-T, GTV-N, CTV or irradiated areas) or out-of-field failures

Disease free survival at 5 years follow-up

Overall survival from beginning of treatment to death of any cause

Explorative analysis of total circulating free DNA (cfDNA)

Health related quality of life (EORTC QLQ-ANL27)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
FDG-PET and Circulating HPV in Patients With Cervical Cancer	NCT02388698	Cervical Cancer	Cervical swab PET-CT Plasma HPV	18 Years -	Sunnybrook Health Sciences Centre
NOAC9 - Circulating Tumor DNA Guided Follow-Up in Anal Cancer	NCT05572801	Anal Cancer	AMR B: HPV posi...	18 Years -	Aarhus University Hospital

Spots Global Cancer Trial Database for plasma hpv

Every month we try and update this database with for plasma hpv cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for plasma hpv

Every month we try and update this database with for plasma hpv cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for plasma hpv cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.